Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
Head and Neck Cancer, Pembrolizumab, Carcinoma, HNSCC
Brief summary
CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC) The secondary objectives are to: * To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC * To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC * To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.
Detailed description
Former Sponsor Checkmate Pharmaceuticals
Interventions
DRUGCMP-001
Subjects will receive CMP-001 10mg weekly for 2 doses after which CMP-001 will be administered every 3 weeks. The first dose of CMP-001 may be administered subcutaneously (SC) or Intratumorally (IT) at the discretion of Investigator. All subsequent doses will be injected intratumorally every 3 weeks (Q3W).
DRUGPembrolizumab
Pembrolizumab 200 mg IV is administered Q3W.
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically- or cytologically-confirmed recurrent or metastatic HNSCC considered incurable by local therapies. * No prior systemic therapy in the recurrent or metastatic setting. Systemic therapy as part of multi-modal treatment for locally advanced disease is allowed. * Primary tumor locations of oropharynx, oral cavity, hypopharynx, larynx or paranasal sinus. Participants may not have a primary tumor site of nasopharynx (any histology). * Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable. * Combined Positive Score (CPS) ≥ 1 for PD-L1 on Immunohistochemistry (IHC) of tumor tissue. * Have results of tumor HPV p16 by IHC for oropharyngeal cancer. * Measurable disease as defined by RECIST v1.1, and both of the following: 1. At least 1 lesion amenable to repeated Intratumoral (IT) injection. 2. Documented disease progression in any lesion that was previously radiated in order to serve as a target lesion. * Adequate organ function based on most recent laboratory values within 3 weeks before the first dose of study drug on Week 1 Day 1 (W1D1) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening. * Capable of understanding and complying with protocol requirements. * Women of childbearing potential must have negative serum pregnancy test during Screening and be willing to use an adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug. * Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug. * Able and willing to provide written informed consent and to follow study instructions. * Subjects unable to provide written informed consent on their own behalf will not be eligible for the study.
Exclusion criteria
* Disease suitable for local therapy administered with curative intent. * Has PD within 3 months of completion of curatively intent systemic treatment for locoregionally advanced HNSCC. * Radiation therapy (or other non-systemic therapy) within 2 weeks before the first dose of study drug on W1D1. * Received prior therapy with PD-1 or PD-L1 blocking antibody therapy in the recurrent/ metastatic setting. If PD-1 or PD-L1 blocking antibody therapy was given as part of curative intent therapy, it must be at least 1 year since receipt of PD-1 or PD-L1 blocking antibody. * Not fully recovered from adverse events (to Grade 1 or less \[per CTCAE v5.0\]), with the exception of persistent alopecia, neuropathy, ototoxicity, hypothyroidism, pain, or dysphagia, due to prior treatment. * Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone within 30 days before the first dose of study drug on W1D1. 1. Subjects who are currently receiving steroids at a prednisone-equivalent dose of ≤ 10 mg/day do not need to discontinue steroids prior to enrollment. 2. Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted. * Active pneumonitis, history of noninfectious pneumonitis that required steroids, or history of interstitial lung disease. * Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, implanted or continuous use of a pacemaker or defibrillator. * Known history of immunodeficiency. * Known additional malignancy that is progressing or required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, and thyroid cancer (except anaplastic). * Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment * Untreated, symptomatic, or enlarging central nervous system (CNS) metastases or carcinomatous meningitis. * Prior allogenic tissue/solid organ transplant. * Active infection requiring systemic therapy. * Known or suspected active infection with SARS-CoV-2 virus. * Known or suspected infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus; testing is not required unless suspected. * Received a live virus vaccination within 30 days before the start of study drug dosing on W1D1. * Received blood products (including platelets or red blood cells) or colony stimulating factors \[including granulocyte colony-stimulating factor (GCSF), granulocyte-macrophage colony-stimulating factor (GMCSF) (or recombinant erythropoietin)\] within 30 days before the start of Screening. * Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial. * Participation in another clinical trial of an investigational anticancer therapy or device within 30 days before the first dose of study drug. * Requires prohibited treatment (ie. non-protocol specified anticancer pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant tumor). * Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating Investigator. * Received previous CMP-001 treatment. * Pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, from the time of consent until at least 120 days after the last dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed Objective Response Rate (ORR) | Up to approximately 109 weeks | Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Up to approximately 109 weeks | NI CTCAE Adverse Event Grades: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event |
| Duration of Response (DOR) | Up to approximately 28 months (120 weeks) | DOR, defined as the time from date of first documented response (CR or PR) to date of documented PD, based on RECIST v1.1 by Investigator assessment (IA). |
| Duration of Progression-free Survival (PFS) | Up to approximately 28 months (120 weeks) | Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first. |
| Duration of Overall Survival (OS) | From first dose up to approximately 28 months (120 weeks) | Overall survival (OS) is defined as the time from the first dose date of the study treatment to the date of death from any cause. |
| Immune Objective Response Rate (iORR) | Up to approximately 109 weeks | Immune objective response rate (iORR), defined as the percentage of participants who have an immune best overall response (iBOR) of immune complete response (iCR) or immune partial response (iPR) based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) as determined by Investigator. |
| Immune Progression-free Survival (iPFS) | Up to approximately 28 months (120 weeks) | iPFS, defined as the time from date of first dose of study drug to date of immune Confirmed Progressive Disease (iCPD) based on immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by IA or death, whichever occurs first. |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Up to approximately 109 weeks | TEAE is defined as an AE that started or worsened in severity on or after the date that study drug was first administered (W1D1) until 30 days after the last dose of study treatment. |
| Confirmed ORR Based on Programmed Death-ligand 1 (PD-L1) Expressions | Up to approximately 109 weeks | Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA) based on PD-L1 expressions (combined positive score \[CPS\] ≥ 1 and CPS ≥ 20) |
| Duration of PFS Based on HPV Status | Up to approximately 28 months (120 weeks) | Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first. PFS based on HPV status |
| Immune Duration of Response (iDOR) | Up to approximately 28 months (120 weeks) | iDOR, defined as the time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) by IA. |
| DOR Based on HPV Status | Up to approximately 28 months (120 weeks) | DOR, defined as the time from date of first documented response (CR or PR) to date of documented PD, based on RECIST v1.1 by Investigator assessment (IA). DOR based on HPV status. |
| DOR Based on PD-L1 Expressions | Up to approximately 28 months (120 weeks) | DOR, defined as the time from date of first documented response (CR or PR) to date of documented PD, based on RECIST v1.1 by Investigator assessment (IA). DOR based on PD-L1 expressions (combined positive score \[CPS\] 20). |
| PFS Based on PD-L1 Expressions | Up to approximately 28 months (120 weeks) | Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first. PFS based on PD-L1 expressions (combined positive score \[CPS\] 20). |
| Confirmed ORR Based on Human Papillomavirus (HPV) Status | Up to approximately 109 weeks | Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA) based on HPV status. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A Participants received CMP-001 intratumorally (IT) and pembrolizumab intravenously (IV) according to treatment schedule A. | 17 |
| CMP-001 IT + Pembrolizumab - Schedule B Participants received CMP-001 IT and pembrolizumab IV according to treatment schedule B. | 7 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 11 | 7 |
| Overall Study | Not Listed | 1 | 0 |
| Overall Study | Sponsor Decision | 3 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | CMP-001 IT + Pembrolizumab - Schedule A | CMP-001 IT + Pembrolizumab - Schedule B | Total |
|---|---|---|---|
| Age, Continuous | 64.1 Years STANDARD_DEVIATION 8.57 | 71.0 Years STANDARD_DEVIATION 10.33 | 66.1 Years STANDARD_DEVIATION 9.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 7 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 4 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 17 | 7 / 7 |
| other Total, other adverse events | 17 / 17 | 6 / 7 |
| serious Total, serious adverse events | 7 / 17 | 5 / 7 |
Outcome results
Primary
Confirmed Objective Response Rate (ORR)
Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA).
Time frame: Up to approximately 109 weeks
Population: Treated Analysis Set (All participants who received at least 1 dose of CMP-001)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Confirmed Objective Response Rate (ORR) | 17.6 Percentage of participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Confirmed Objective Response Rate (ORR) | 0 Percentage of participants |
Secondary
Confirmed ORR Based on Human Papillomavirus (HPV) Status
Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA) based on HPV status.
Time frame: Up to approximately 109 weeks
Population: Subgroup of participants in Treated Analysis Set that completed HPV testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Confirmed ORR Based on Human Papillomavirus (HPV) Status | HPV positive | 16.7 Percentage of participants |
| CMP-001 IT + Pembrolizumab - Schedule A | Confirmed ORR Based on Human Papillomavirus (HPV) Status | HPV negative | 25.0 Percentage of participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Confirmed ORR Based on Human Papillomavirus (HPV) Status | HPV positive | 0 Percentage of participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Confirmed ORR Based on Human Papillomavirus (HPV) Status | HPV negative | 0 Percentage of participants |
Secondary
Confirmed ORR Based on Programmed Death-ligand 1 (PD-L1) Expressions
Confirmed ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by Investigator assessment (IA) based on PD-L1 expressions (combined positive score \[CPS\] ≥ 1 and CPS ≥ 20)
Time frame: Up to approximately 109 weeks
Population: Subgroup of participants in Treated Analysis Set that had PL-1 expressions; For 1 participant, the site used a local, qualitative test (positive/negative). Therefore, the CPS (%) is missing for this 1 participant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Confirmed ORR Based on Programmed Death-ligand 1 (PD-L1) Expressions | PD-L1 Expression: 1 to < 20 | 20.0 Percentage of participants |
| CMP-001 IT + Pembrolizumab - Schedule A | Confirmed ORR Based on Programmed Death-ligand 1 (PD-L1) Expressions | PD-L1 Expression: >= 20 | 14.3 Percentage of participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Confirmed ORR Based on Programmed Death-ligand 1 (PD-L1) Expressions | PD-L1 Expression: 1 to < 20 | 0 Percentage of participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Confirmed ORR Based on Programmed Death-ligand 1 (PD-L1) Expressions | PD-L1 Expression: >= 20 | 0 Percentage of participants |
Secondary
DOR Based on HPV Status
DOR, defined as the time from date of first documented response (CR or PR) to date of documented PD, based on RECIST v1.1 by Investigator assessment (IA). DOR based on HPV status.
Time frame: Up to approximately 28 months (120 weeks)
Population: Number of participants analyzed for DOR based on HPV status includes only participants who have a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) to date of documented PD and completed HPV testing.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | DOR Based on HPV Status | HPV negative | NA Months |
| CMP-001 IT + Pembrolizumab - Schedule A | DOR Based on HPV Status | HPV positive | NA Months |
Secondary
DOR Based on PD-L1 Expressions
DOR, defined as the time from date of first documented response (CR or PR) to date of documented PD, based on RECIST v1.1 by Investigator assessment (IA). DOR based on PD-L1 expressions (combined positive score \[CPS\] 20).
Time frame: Up to approximately 28 months (120 weeks)
Population: Number of participants analyzed for DOR based on PD-L1 expressions included only participants with confirmed BOR of CR or PR and CPS \>=20. Here, 0 participants met the criteria.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | DOR Based on PD-L1 Expressions | NA Months |
Secondary
Duration of Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose date of the study treatment to the date of death from any cause.
Time frame: From first dose up to approximately 28 months (120 weeks)
Population: Treated Analysis Set (All participants who received at least 1 dose of CMP-001)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Duration of Overall Survival (OS) | 6.932 Months |
| CMP-001 IT + Pembrolizumab - Schedule B | Duration of Overall Survival (OS) | 7.129 Months |
Secondary
Duration of PFS Based on HPV Status
Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first. PFS based on HPV status
Time frame: Up to approximately 28 months (120 weeks)
Population: Subgroup of participants in Treated Analysis Set that completed HPV testing
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Duration of PFS Based on HPV Status | HPV positive | 3.253 Months |
| CMP-001 IT + Pembrolizumab - Schedule A | Duration of PFS Based on HPV Status | HPV negative | 1.183 Months |
| CMP-001 IT + Pembrolizumab - Schedule B | Duration of PFS Based on HPV Status | HPV positive | 3.975 Months |
| CMP-001 IT + Pembrolizumab - Schedule B | Duration of PFS Based on HPV Status | HPV negative | 1.807 Months |
Secondary
Duration of Progression-free Survival (PFS)
Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first.
Time frame: Up to approximately 28 months (120 weeks)
Population: Treated Analysis Set (All participants who received at least 1 dose of CMP-001)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Duration of Progression-free Survival (PFS) | 2.103 Months |
| CMP-001 IT + Pembrolizumab - Schedule B | Duration of Progression-free Survival (PFS) | 1.807 Months |
Secondary
Duration of Response (DOR)
DOR, defined as the time from date of first documented response (CR or PR) to date of documented PD, based on RECIST v1.1 by Investigator assessment (IA).
Time frame: Up to approximately 28 months (120 weeks)
Population: Number of participants analyzed for DOR includes only participants who have a confirmed best overall response (BOR) of complete response (CR) or partial response (PR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Duration of Response (DOR) | NA Months |
Secondary
Immune Duration of Response (iDOR)
iDOR, defined as the time from the date of the first immune response (iCR or iPR) to the date of immune confirmed progressive disease (iCPD) by IA.
Time frame: Up to approximately 28 months (120 weeks)
Population: Number analyzed = Number of participants who had iBOR of immune complete response (iCR) or immune partial response (iPR). Here, 0 participants met the criteria.
Secondary
Immune Objective Response Rate (iORR)
Immune objective response rate (iORR), defined as the percentage of participants who have an immune best overall response (iBOR) of immune complete response (iCR) or immune partial response (iPR) based on the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) as determined by Investigator.
Time frame: Up to approximately 109 weeks
Population: Treated Analysis Set (All participants who received at least 1 dose of CMP-001)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Immune Objective Response Rate (iORR) | 0 Percentage of participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Immune Objective Response Rate (iORR) | 0 Percentage of participants |
Secondary
Immune Progression-free Survival (iPFS)
iPFS, defined as the time from date of first dose of study drug to date of immune Confirmed Progressive Disease (iCPD) based on immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST) by IA or death, whichever occurs first.
Time frame: Up to approximately 28 months (120 weeks)
Population: Number analyzed = Number of participants continuing study treatment beyond PD.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Immune Progression-free Survival (iPFS) | 9.955 Months |
| CMP-001 IT + Pembrolizumab - Schedule B | Immune Progression-free Survival (iPFS) | NA Months |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
TEAE is defined as an AE that started or worsened in severity on or after the date that study drug was first administered (W1D1) until 30 days after the last dose of study treatment.
Time frame: Up to approximately 109 weeks
Population: Treated Analysis Set (All participants who received at least 1 dose of CMP-001)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE | 17 Participants |
| CMP-001 IT + Pembrolizumab - Schedule A | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any serious TEAE | 7 Participants |
| CMP-001 IT + Pembrolizumab - Schedule A | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to death | 1 Participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE | 7 Participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any serious TEAE | 5 Participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to death | 0 Participants |
Secondary
PFS Based on PD-L1 Expressions
Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on RECIST v1.1 by IA or death, whichever occurs first. PFS based on PD-L1 expressions (combined positive score \[CPS\] 20).
Time frame: Up to approximately 28 months (120 weeks)
Population: Number of participants analyzed for PFS based on PD-L1 expressions included only participants with documented PD or death and CPS \>=20. Here, 0 participants met the criteria.
Secondary
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
NI CTCAE Adverse Event Grades: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event
Time frame: Up to approximately 109 weeks
Population: Treated Analysis Set (All participants who received at least 1 dose of CMP-001)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CMP-001 IT + Pembrolizumab - Schedule A | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Grade 3 | 7 Participants |
| CMP-001 IT + Pembrolizumab - Schedule A | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Grade 4 | 2 Participants |
| CMP-001 IT + Pembrolizumab - Schedule A | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Grade 5 | 1 Participants |
| CMP-001 IT + Pembrolizumab - Schedule A | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Grade 1 - 2 | 7 Participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Grade 1 - 2 | 1 Participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Grade 3 | 6 Participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Grade 5 | 0 Participants |
| CMP-001 IT + Pembrolizumab - Schedule B | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | Grade 4 | 0 Participants |