Medullary Thyroid Cancer (MTC)
Conditions
Keywords
Anti-PD1/PDL1, Vaccine Therapy, TKI-Naive
Brief summary
Background: Medullary thyroid cancer (MTC) is a tumor of the thyroid gland. Surgery is the only current treatment to cure it. The drug pembrolizumab (MK-3475) is a new type of cancer therapy. It works by allowing the immune system to detect and kill tumor cells. Objective: To test how pembrolizumab affects people with MTC and if it can offer them clinical benefit. Eligibility: People ages 18 and older with MTC Patients who have recurrent or metastatic MTC, for whom surgery is not a curative option Patients with some imaging evidence of MTC Patients with minimal symptoms related to MTC Design: Participants will be screened with: * Medical history * Physical exam * Blood, urine, and heart tests * Computed tomography (CT) scan or magnetic resonance imaging (MRI): They lie in a machine that takes pictures of the body. * Bone scan Participants will be put in a group based on their treatment history: * Group 1 if they have had an immune stimulating cancer vaccine * Group 2 if they have had no vaccine Participants will receive the study drug as a 30-minute intravenous (IV) infusion every 3 weeks. Treatment will continue for up to 2 years as long as they tolerate it and their disease does not get worse. Participants will have physical exams and blood tests on the day of each infusion. They will have CT and bone scans every 3 months. Participants may save biopsies before treatment and after starting treatment. Participants will have a final visit 3-4 weeks after stopping treatment. This will include a physical exam and blood and heart tests. After this study, participants can join a long-term follow-up study.
Detailed description
Background: * Anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PDL1) therapies have had clinical success in a minority of unselected patients across multiple tumor types * While many questions remain about optimal PD1/PDL1 staining techniques to pre-select responders, less focus is being place on how to optimize responses in a broader cohort of patients * Emerging preclinical and clinical data supports the hypothesis that a strong immunologic response in the tumor microenvironment induces PDL1 expression on the tumor and is associated with better clinical response to anti-PD1/PDL1 therapies * Therapeutic cancer vaccines are one strategy to induce an immunologic response to the tumor, thereby enhancing PDL1 expression and optimizing clinical responses across all patients * Limited clinical data exists about the potential benefit of sequential therapy with a therapeutic cancer vaccine followed by PD1/PDL1 inhibition * This study will explore the role of PD1 inhibition in medullary thyroid cancer and evaluate the potential differences based on previous vaccine therapy Objective: -The primary objective of this trial is to determine whether administering a PD1 inhibitor to patients with medullary thyroid cancer will permit a modest fraction to be able to experience a 50% or greater decline in calcitonin levels or experience a partial/complete response on imaging Key Eligibility: * Patients greater than or equal to 18 years of age with evidence of metastatic medullary thyroid cancer including disease that is evaluable on bone, computed tomography (CT) scan or magnetic resonance imaging (MRI) * Must have elevated calcitonin levels greater than 40 pg/mL * Patients with minimal or no disease related-symptoms (minimal symptoms will include those that do not affect activities of daily living or pain that does not require regularly schedule narcotics) * Eastern Cooperative Oncology Group (ECOG) 0-1 * Should have no autoimmune diseases; no evidence of being immunocompromised; no serious inter-current medical illness * No brain metastasis, history of seizures, encephalitis, or multiple sclerosis Design: * This is a phase II, open label, single center clinical trial where all patients receive the anti-PD1/PDL1 therapy pembrolizumab * Patients will enroll in one of two cohorts: patients with previous vaccine therapy or patients without previous vaccine therapy * All patients will be TKI naive with minimal symptoms (consistent with the eligibility for our current study) * Based on our calcitonin findings with our current study of 30 patients, we have determined that a confirmed calcitonin decline of 50% would be a rare finding, providing compelling preliminary evidence of clinical activity * A total of 30 patients will be enrolled in the proposed study (15 patients in each cohort). Given that we already have 30 patients on a study with vaccine, we would only need to identify and recruit 15 patients for the vaccine-naive cohort. * Based on these metrics, we could have \>6 months of calcitonin data in 30 patients within 2 years from trial initiation * Additional immune correlative capitalizing on the extensive immune monitoring experience of the Laboratory of Tumor Immunology and Biology (LTIB) will allow for assessments of antigen specific T-cells and 123 immune subsets. These findings could provide the basis for biomarker development when taken together with biochemical and clinical responses seen in this study
Interventions
Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
* INCLUSION CRITERIA: * Diagnosis: Patients must have histologically confirmed medullary thyroid cancer by the Laboratory of Pathology or a pathology report and history consistent with medullary thyroid cancer. It is not uncommon for a secondary, minor pathologic focus of another form of thyroid cancer to be coincidentally found in 15-20% of patients with medullary thyroid cancer. In such cases, eligibility is based on the discretion of the investigator. * Patients must have evidence of metastatic medullary thyroid cancer including disease that is evaluable on bone, computed tomography (CT) scan or magnetic resonance imaging (MRI). (Patients who are surgical candidates and potentially rendered disease free with surgical resection are not eligible.) * Patients must have elevated calcitonin levels greater than 40 pg/mL * Patients must have minimal or no disease related-symptoms (Minimal symptoms will include those that do not affect activities of daily living or pain that does not require regularly scheduled narcotics.) * Patients must have evaluable disease on imaging * No history of seizures, encephalitis, or multiple sclerosis. * Age greater than or equal to 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry (Karnofsky greater than or equal to 70). * Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Female subjects of childbearing potential must be willing to use an adequate method of contraception, Contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject * Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject * Willing to travel to the National Institutes of Health (NIH) for follow-up visits * Able to understand and sign informed consent. * Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation. * Adequate Organ Function Laboratory Values * Hematological ---Absolute neutrophil count (ANC) greater than or equal to1,000 /mcL * Platelets greater than or equal to 100,000 / mcL * Hemoglobin greater than or equal to 9 g/dL or greater than or equal to 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) * Renal * Serum creatinine less than or equal to1.5 X upper limit of normal (ULN) OR * Measured or calculated\* creatinine clearance (Glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl) greater than or equal to 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN * Hepatic * Serum total bilirubin less than or equal to 1.5 X ULN OR Direct bilirubin less than or equal to ULN for subjects with total bilirubin levels \> 1.5 ULN * Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT) and Alanine aminotransferase (ALT) Serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 X ULN OR less than or equal to 5 X ULN for subjects with liver metastases * Albumin \>2.5 mg/dL * Coagulation * International Normalized Ratio (INR) or Prothrombin Time (PT) less than or equal to1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants * Activated Partial Thromboplastin Time (aPTT) less than or equal to1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Creatinine clearance should be calculated per Cockcroft-Gault equation
Exclusion criteria
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. * Has a known history of active TB (Bacillus Tuberculosis) * Hypersensitivity to pembrolizumab or any of its excipients. * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has had prior targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with less than or equal to Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable for 6 months (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subjects participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has received prior therapy with an anti-Programmed cell death protein 1 (PD-1), anti- programmed cell death-1 ligand 1 (PD-L1), or anti-Programmed death ligand 2 (PD-L2) agent. * Has Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\] is detected). * Has received a live vaccine within 30 days of planned start of study therapy * Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, eye drops or inhaled) steroid use. Limited doses of systemic steroids (e.g., in patients with exacerbations of reactive airway disease or to prevent intravenous (IV) contrast allergic reaction or anaphylaxis in patients who have known contrast allergies) are allowed. * Serious inter-current medical illness which would interfere with the ability of the patient to carry out the treatment program. * Patients with second malignancy within 3 years of enrollment; Patients curatively treated non-melanoma skin cancers or carcinoma in situ of the bladder, are not excluded. Patients with Multiple endocrine neoplasia type 2 (MEN2) and a history of pheochromocytoma will also not be excluded. In addition, patients with prostate cancer who do not require systemic therapy will not be excluded. (A secondary, minor pathologic focus of another form of thyroid cancer may be coincidentally found in 15-20% of patients with medullary thyroid cancer. In such cases, eligibility is based on the discretion of the investigator.) * Patients with previous history of vandetanib or cabozantinib treatment for more than 28 days of treatment (patients have discontinued treatment for 28 days before enrolling).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response | 2 years | Participants with medullary thyroid cancer were administered a programmed cell death protein 1 (PD1) inhibitor to determine if any experienced a 50% or greater decline in calcitonin levels. A calcitonin response is defined as participants with a ≥50% decline from baseline that is then confirmed on a subsequent calcitonin assessment at least one week later. |
| Percentage of Participants With a Partial Response and Complete Response by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | 2 years | Participants were imaged by CT or MRI and followed for response using the Immune-Related Response Criteria (irRC). Partial Response is a ≥30% decrease in the sum of the largest diameter (SLD) compared with baseline confirmed by a consecutive assessment at least 4 weeks after the first documentation. Complete Response is a 100% disappearance of all lesions, whether measurable or not, and no new lesions, in two consecutive observations not less than 4 weeks from the date first documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Sustained Decline in Calcitonin | every 3 weeks while on treatment and post treatment, up to 2 years | A sustained 50% decline in calcitonin. A large magnitude decline in calcitonin may be associated with tumor responses. |
| Progression-free Survival (PFS) | 3 weeks for up to 2 years while on treatment than 2 weeks after last treatment | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression, assessed by the Immune-Related Response Criteria (irRC), is defined as at least 20% increase in the sum of the largest diameter (SLD) compared with nadir (minimum recorded tumor burden) and an increase of at least 5mm over the nadir, confirmed by a repeat,consecutive observations at least 4 weeks from the date first documented. |
| Overall Survival at 2 Years | 2 years | Percentage of participants who are alive at 2 years. |
| Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants | Day 1 and 84 days | Regulatory T-Cells (CD4, CD8, Tregs, and NK cells) in peripheral blood mononuclear cell (PBMC)s were measured by 7-color flow cytometry. |
| Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2. | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant but not immediately life-threatening. Grade 4 is life-threatening; urgent intervention indicated. Grade 5 is death related to adverse event. |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2. | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant but not immediately life-threatening. Grade 4 is life-threatening; urgent intervention indicated. Grade 5 is death related to adverse event. |
| Number of Participants With a Sustained Decline in Carcinoembryonic Antigen (CEA) | every 3 weeks while on treatment and post treatment, up to 2 years | A sustained 50% decline in CEA. A large magnitude decline in CEA may be associated with tumor responses. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Cancer Vaccine Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.
Group 1: cancer vaccine
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. | 13 |
| Cohort 2: Participants That Have Had No Vaccine Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks for two years.
Group 2: had no previous vaccine
Pembrolizumab: Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. | 4 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Disease progression on study | 1 | 1 |
| Overall Study | No contact | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Refused further treatment | 6 | 1 |
Baseline characteristics
| Characteristic | Cohort 2: Participants That Have Had No Vaccine | Cohort 1: Cancer Vaccine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 10 Participants | 12 Participants |
| Age, Continuous | 59.48 years STANDARD_DEVIATION 11.85 | 52.82 years STANDARD_DEVIATION 11.8 | 56.15 years STANDARD_DEVIATION 11.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 11 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Median Baseline Calcitonin | 6000 pg/ml | 509 pg/ml | 6000 pg/ml |
| Median Baseline Carcinoembryonic Antigen (CEA) | 207 ng/ml | 125 ng/ml | 175 ng/ml |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 13 Participants |
| Region of Enrollment United States | 4 participants | 13 participants | 17 participants |
| Sex: Female, Male Female | 3 Participants | 10 Participants | 13 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 2 / 4 |
| other Total, other adverse events | 13 / 13 | 3 / 4 |
| serious Total, serious adverse events | 2 / 13 | 2 / 4 |
Outcome results
Clinical Response
Participants with medullary thyroid cancer were administered a programmed cell death protein 1 (PD1) inhibitor to determine if any experienced a 50% or greater decline in calcitonin levels. A calcitonin response is defined as participants with a ≥50% decline from baseline that is then confirmed on a subsequent calcitonin assessment at least one week later.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Cancer Vaccine | Clinical Response | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Clinical Response | 0 Participants |
Percentage of Participants With a Partial Response and Complete Response by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Participants were imaged by CT or MRI and followed for response using the Immune-Related Response Criteria (irRC). Partial Response is a ≥30% decrease in the sum of the largest diameter (SLD) compared with baseline confirmed by a consecutive assessment at least 4 weeks after the first documentation. Complete Response is a 100% disappearance of all lesions, whether measurable or not, and no new lesions, in two consecutive observations not less than 4 weeks from the date first documented.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Cancer Vaccine | Percentage of Participants With a Partial Response and Complete Response by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Percentage of Participants With a Partial Response and Complete Response by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | 0 Participants |
Number of Participants With a Sustained Decline in Calcitonin
A sustained 50% decline in calcitonin. A large magnitude decline in calcitonin may be associated with tumor responses.
Time frame: every 3 weeks while on treatment and post treatment, up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Cancer Vaccine | Number of Participants With a Sustained Decline in Calcitonin | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With a Sustained Decline in Calcitonin | 0 Participants |
Number of Participants With a Sustained Decline in Carcinoembryonic Antigen (CEA)
A sustained 50% decline in CEA. A large magnitude decline in CEA may be associated with tumor responses.
Time frame: every 3 weeks while on treatment and post treatment, up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Cancer Vaccine | Number of Participants With a Sustained Decline in Carcinoembryonic Antigen (CEA) | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With a Sustained Decline in Carcinoembryonic Antigen (CEA) | 0 Participants |
Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant but not immediately life-threatening. Grade 4 is life-threatening; urgent intervention indicated. Grade 5 is death related to adverse event.
Time frame: Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 2 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 6 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 2 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 3 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 4 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 3 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 2 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 2 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 1 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 1 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 1 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 1 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 1 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 1 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 2 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 2 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 2 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 1 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 1 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 1 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 1 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 2 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 1 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 1 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 1 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 1 Participants |
| Cohort 2: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Aspartate aminotransferase | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Hearing impaired | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Neutrophil count decreased | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flu-like symptoms | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Alanine aminotransferase | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Acute kidney injury | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash maculopapular | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dry eye | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pain of skin | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Arthralgia | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Platelet count decreased | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Flashing lights | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Pruritis | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Skin and subcutaneous tissue disorders | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Injection site reaction | 0 Participants |
| Cohort 2: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Possibly, Probably, or Definitely Related to Pembrolizumab | Renal and urinary disorders | 0 Participants |
Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant but not immediately life-threatening. Grade 4 is life-threatening; urgent intervention indicated. Grade 5 is death related to adverse event.
Time frame: Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 1 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 1: Cancer Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 3 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 4 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 6 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 4 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 4 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 1 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 2 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 8 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 00 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 1 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 2 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 3 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 3 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 2 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 2 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 1 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 1: Grade 2 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 1 Participants |
| Cohort 1: Grade 2 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 1 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 1 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 1 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 2 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 1 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 1 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 1 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 1 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 1 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 1: Grade 3 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 2 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 1 Participants |
| Cohort 1: Grade 3 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 1 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 00 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 1 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 1 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 1: Grade 3 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 2 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 1 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 0 Participants |
| Cohort 2: Grade 1 Possibly Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 2: Grade 1 Probably Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Upper respiratory infection | 1 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | White blood cell decreased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoglycemia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain in extremity | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nasal congestion | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypercalcemia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nail ridging | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Menopause | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Skin infection | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyponatremia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypokalemia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypocalcemia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Paresthesia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Generalized muscle weakness | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | General disorders & admin. site conditions | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye disorders | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Peripheral motor neuropathy | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Creatinine increased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Aspartate aminotransferase increased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rhinitis infective | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Wheezing | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Allergic rhinitis | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lip pain | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Ear and labyrinth disorders | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Insomnia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypernatremia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dyspnea | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypoalbuminemia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Gait disturbance | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Fatigue | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Diarrhea | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Headache | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cough | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Back pain | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry mouth | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Pain | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flank pain | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dizziness | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema face | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Blood bilirubin increased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Neck pain | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Nausea | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Flushing | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperglycemia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dehydration | 1 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | CPK increased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Buttock pain | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Lymphocyte count decreased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Eye pain | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anemia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Dry skin | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Alanine aminotransferase increased | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Presyncope | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Rash acneiform | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypotension | 1 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Anorexia | 1 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Abdominal pain | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Cataract | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hypomagnesemia | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Enterocolitis | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Edema limbs | 0 Participants |
| Cohort 2: Grade 1 Definitely Related | Number of Participants With Grade ≥1 Adverse Events Unlikely or Unrelated to Pembrolizumab | Hyperuricemia | 0 Participants |
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Date treatment consent signed to date off study, approximately 25 months and 28 days for cohort 1 and 18 months and 12 days for cohort 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Cancer Vaccine | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 13 Participants |
| Cohort 2: Participants That Have Had No Vaccine | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 4 Participants |
Overall Survival at 2 Years
Percentage of participants who are alive at 2 years.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Cancer Vaccine | Overall Survival at 2 Years | 100 percentage of participants |
| Cohort 2: Participants That Have Had No Vaccine | Overall Survival at 2 Years | 50 percentage of participants |
Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants
Regulatory T-Cells (CD4, CD8, Tregs, and NK cells) in peripheral blood mononuclear cell (PBMC)s were measured by 7-color flow cytometry.
Time frame: Day 1 and 84 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort 1: Cancer Vaccine | Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants | CD4 | 34.73 Percentage change |
| Cohort 1: Cancer Vaccine | Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants | CD8 | 13.70 Percentage change |
| Cohort 1: Cancer Vaccine | Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants | Tregs | 0.70 Percentage change |
| Cohort 1: Cancer Vaccine | Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants | NK | 10.47 Percentage change |
| Cohort 2: Participants That Have Had No Vaccine | Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants | NK | 10.26 Percentage change |
| Cohort 2: Participants That Have Had No Vaccine | Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants | CD4 | 33.95 Percentage change |
| Cohort 2: Participants That Have Had No Vaccine | Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants | Tregs | 0.77 Percentage change |
| Cohort 2: Participants That Have Had No Vaccine | Percentage Change in (Cluster of Differentiation 4 (CD4), CD8, Tregs, and Natural Killer (NK) Cells at Day 1 and 84 Days in All Participants | CD8 | 12.50 Percentage change |
Progression-free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression, assessed by the Immune-Related Response Criteria (irRC), is defined as at least 20% increase in the sum of the largest diameter (SLD) compared with nadir (minimum recorded tumor burden) and an increase of at least 5mm over the nadir, confirmed by a repeat,consecutive observations at least 4 weeks from the date first documented.
Time frame: 3 weeks for up to 2 years while on treatment than 2 weeks after last treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Cancer Vaccine | Progression-free Survival (PFS) | 210 Days |
| Cohort 2: Participants That Have Had No Vaccine | Progression-free Survival (PFS) | 55 Days |