Cancer
Conditions
Keywords
ICOS, ICOS agonist monoclonal antibody, JTX-2011, Anti-PD-1, Nivolumab, ICONIC, Immunotherapy, Immuno-oncology, Cancer, Solid Tumor, Dose Escalation, Dose Expansion, Anti-CTLA-4, Ipilimumab, Pembrolizumab
Brief summary
JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
Detailed description
JTX-2011 is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.
Interventions
DRUGJTX-2011
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
DRUGIpilimumab
Specified dose on specified days
DRUGPembrolizumab
Specified dose on specified days
Sponsors
Jounce Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures 2. Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, and meet the requirements for the intended study cohort 3. Male or Female ≥ 18 years of age 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Subjects with ECOG 2 may be considered for enrollment in Parts C, D, F, and H if approved by Medical Monitor 5. Have a predicted life expectancy of ≥ 3 months 6. Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance with the study protocol 7. If medical history of the following, case should be reviewed by the Medical Monitor: prior biliary tract disorders (as based on Hepatobiliary SOC high level terms of: obstructive bile duct disorders, hepatic vascular disorders, structural and other bile duct disorders) or portal hypertension and/or hepatic vascular disorders 8. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of JTX-2011 9. WOCBP and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment
Exclusion criteria
1. Receiving concurrent anti-cancer treatment (excluding radiation therapy), either approved or investigational 2. Have refused standard therapy 3. Have received anti-cancer therapies listed below within the specified timeframe, or who have ongoing toxicity from prior therapy \> Grade 1 according to the Common Terminology for Adverse Events (CTCAE). Exceptions to this are: \> Grade 1 toxicities which in the opinion of the Investigator should not exclude the subject (e.g. alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism or other endocrinopathies that are well-controlled with hormone replacement) and are approved by the Medical Monitor. 1. Have received biologic therapy, including immunotherapy, \< 28 days prior to C1D1; 2. Have received CAR-T therapy; 3. Have received chemotherapy \< 21 days prior to C1D1, or \< 42 days for mitomycin or nitrosoureas; 4. Have received targeted small molecule therapy \< 14 days prior to C1D1; 5. Have undergone organ transplantation including allogeneic or autologous stem-cell transplantation, at any time; 4. Have undergone a major surgery (excluding minor procedures, e.g. placement of vascular access, biopsy, etc.) \< 6 months prior to the first day of study treatment, C1D1 5. Have a history of intolerance, hypersensitivity, or treatment discontinuation due to severe immune adverse events on prior immunotherapy, or documented presence of neutralizing anti-drug antibody to nivolumab, ipilimumab, or pembrolizumab. Subjects who discontinued prior immunotherapies for immune-related adverse events that are well-controlled with appropriate treatment may be enrolled if approved by the Medical Monitor. 6. Have a diagnosis of immunodeficiency, either primary or acquired, or treatment with systemic steroids or any other form of immunosuppressive therapy within 7 days prior to C1D1. Exception: inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease as well as a one-time dose of immunosuppressive agents used prophylactically for contrast allergies 7. Have any active disease requiring systemic immunosuppressive treatment 8. Have known severe intolerance to or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous immunoglobulin preparations; any history of anaphylaxis; prior history of human anti-human antibody response; known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent 9. Are symptomatic or have uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation (brain metastases that are stable and asymptomatic, either treated or untreated, will be allowed) 10. Have current second malignancy at other sites, which requires treatment, or in the judgement of the Investigator, may require treatment within the next year. Concurrent malignancies that do not require treatment and are clinically stable are allowed. A past history of other malignancies is allowed as long as the subject is not receiving specific treatment other than hormonal therapy, and, in the judgement of the Investigator, is unlikely to have a recurrence. 11. Have active and clinically relevant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required) 12. Have received live vaccines within past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date prior to first infusion day) 13. Women who are pregnant or breastfeeding 14. Have experienced symptomatic cardiac disease that is unresponsive to surgical or medical management 15. Have any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical trial data interpretation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | 46.3 months | Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated |
| Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE) | 46.3 months | Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE) | 46.3 months | Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE) | 46.3 months | Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE) | 46.3 months | Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 |
| Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE) | 46.3 months | Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 |
| Number of Participants With Dose Limiting Toxicities | 33 months | Number of participants with at least one dose limiting toxicity (DLT) |
| Overall Response Rate | 46.5 months | Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review |
| Disease Control Rate | 46.5 months | Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose) |
| Progression Free Survival | 46.5 months | Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
| 6 Month Landmark Progression Free Survival | 46.5 months | Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial. |
| 12 Month Landmark Progression Free Survival | 46.5 months | Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial. |
| Landmark Overall Survival at 6 Months | 46.5 months | Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial. |
| Landmark Overall Survival at 12 Months | 46.5 months | Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial. |
| Overall Survival | 46.5 months | The time from first dose date to the date of death for any cause |
Countries
United States
Participant flow
Pre-assignment details
The protocol enrollment number of 242 is the number of participants who signed the ICF. The number that Started the Participant flow module (218) are those subjects who received any amount of study drug (JTX-2011 and/or nivolumab and/or ipilimumab and/or pembrolizumab). The difference between these two values (24) are the number of patients who screen failed.
Participants by arm
| Arm | Count |
|---|---|
| Part A (JTX-2011) Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days | 40 |
| Part B (JTX-2011 + Nivolumab) Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days | 31 |
| Part C (JTX-2011) Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days | 30 |
| Part D (JTX-2011 + Nivolumab) Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days | 100 |
| Part E (JTX-2011 + Ipilimumab) Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days | 11 |
| Part F (JTX-2011 + Ipilimumab) Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days | 0 |
| Part G (JTX-2011 + Pembrolizumab) Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days | 6 |
| Part H (JTX-2011 + Pembrolizumab) Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days | 0 |
| Total | 218 |
Baseline characteristics
| Characteristic | Part B (JTX-2011 + Nivolumab) | Part C (JTX-2011) | Part D (JTX-2011 + Nivolumab) | Part E (JTX-2011 + Ipilimumab) | Part G (JTX-2011 + Pembrolizumab) | Part A (JTX-2011) | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 17 Participants | 36 Participants | 4 Participants | 4 Participants | 12 Participants | 77 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 13 Participants | 64 Participants | 7 Participants | 2 Participants | 28 Participants | 141 Participants |
| Age, Continuous | 56.2 years STANDARD_DEVIATION 9.87 | 64.4 years STANDARD_DEVIATION 10.57 | 61.1 years STANDARD_DEVIATION 9.65 | 58.8 years STANDARD_DEVIATION 9.95 | 65.7 years STANDARD_DEVIATION 8.77 | 60.6 years STANDARD_DEVIATION 10.94 | 60.8 years STANDARD_DEVIATION 10.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 4 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 26 Participants | 91 Participants | 11 Participants | 6 Participants | 35 Participants | 196 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 5 Participants | 0 Participants | 0 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 5 Participants | 2 Participants | 0 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 13 Participants | 1 Participants | 0 Participants | 5 Participants | 28 Participants |
| Race (NIH/OMB) White | 22 Participants | 22 Participants | 77 Participants | 7 Participants | 6 Participants | 29 Participants | 163 Participants |
| Region of Enrollment United States | 31 participants | 30 participants | 100 participants | 11 participants | 6 participants | 40 participants | 218 participants |
| Sex: Female, Male Female | 19 Participants | 13 Participants | 39 Participants | 3 Participants | 3 Participants | 22 Participants | 99 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 61 Participants | 8 Participants | 3 Participants | 18 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 19 / 40 | 19 / 31 | 22 / 30 | 68 / 100 | 6 / 11 | 0 / 0 | 5 / 6 | 0 / 0 |
| other Total, other adverse events | 38 / 40 | 31 / 31 | 30 / 30 | 98 / 100 | 11 / 11 | 0 / 0 | 6 / 6 | 0 / 0 |
| serious Total, serious adverse events | 14 / 40 | 9 / 31 | 16 / 30 | 38 / 100 | 6 / 11 | 0 / 0 | 2 / 6 | 0 / 0 |
Outcome results
Primary
12 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time frame: 46.5 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part A (JTX-2011) | 12 Month Landmark Progression Free Survival | NA Probability of event free at month 12(%) |
| Part B (JTX-2011 + Nivolumab) | 12 Month Landmark Progression Free Survival | 10.2 Probability of event free at month 12(%) |
| Part C (JTX-2011) | 12 Month Landmark Progression Free Survival | 4.1 Probability of event free at month 12(%) |
| Part D (JTX-2011 + Nivolumab) | 12 Month Landmark Progression Free Survival | 4.6 Probability of event free at month 12(%) |
| Part E (JTX-2011 + Ipilimumab) | 12 Month Landmark Progression Free Survival | 0 Probability of event free at month 12(%) |
| Part G (JTX-2011 + Pembrolizumab) | 12 Month Landmark Progression Free Survival | 0 Probability of event free at month 12(%) |
Primary
6 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time frame: 46.5 months
Population: The 95% CI is not estimable by Kaplan-Meier method for Part E since the probability of event was 0.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part A (JTX-2011) | 6 Month Landmark Progression Free Survival | 10.0 Probability of event free at month 6 (%) |
| Part B (JTX-2011 + Nivolumab) | 6 Month Landmark Progression Free Survival | 10.2 Probability of event free at month 6 (%) |
| Part C (JTX-2011) | 6 Month Landmark Progression Free Survival | 4.1 Probability of event free at month 6 (%) |
| Part D (JTX-2011 + Nivolumab) | 6 Month Landmark Progression Free Survival | 9.1 Probability of event free at month 6 (%) |
| Part E (JTX-2011 + Ipilimumab) | 6 Month Landmark Progression Free Survival | 0 Probability of event free at month 6 (%) |
| Part G (JTX-2011 + Pembrolizumab) | 6 Month Landmark Progression Free Survival | 33.3 Probability of event free at month 6 (%) |
Primary
Disease Control Rate
Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)
Time frame: 46.5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A (JTX-2011) | Disease Control Rate | 7 Participants |
| Part B (JTX-2011 + Nivolumab) | Disease Control Rate | 7 Participants |
| Part C (JTX-2011) | Disease Control Rate | 3 Participants |
| Part D (JTX-2011 + Nivolumab) | Disease Control Rate | 23 Participants |
| Part E (JTX-2011 + Ipilimumab) | Disease Control Rate | 2 Participants |
| Part G (JTX-2011 + Pembrolizumab) | Disease Control Rate | 4 Participants |
Primary
Landmark Overall Survival at 12 Months
Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time frame: 46.5 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part A (JTX-2011) | Landmark Overall Survival at 12 Months | 12.2 Probability of event free at month 12(%) |
| Part B (JTX-2011 + Nivolumab) | Landmark Overall Survival at 12 Months | 41.2 Probability of event free at month 12(%) |
| Part C (JTX-2011) | Landmark Overall Survival at 12 Months | 16.0 Probability of event free at month 12(%) |
| Part D (JTX-2011 + Nivolumab) | Landmark Overall Survival at 12 Months | 40.5 Probability of event free at month 12(%) |
| Part E (JTX-2011 + Ipilimumab) | Landmark Overall Survival at 12 Months | 31.1 Probability of event free at month 12(%) |
| Part G (JTX-2011 + Pembrolizumab) | Landmark Overall Survival at 12 Months | 16.7 Probability of event free at month 12(%) |
Primary
Landmark Overall Survival at 6 Months
Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time frame: 46.5 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part A (JTX-2011) | Landmark Overall Survival at 6 Months | 69.4 Probability of event free at month 6 (%) |
| Part B (JTX-2011 + Nivolumab) | Landmark Overall Survival at 6 Months | 61.8 Probability of event free at month 6 (%) |
| Part C (JTX-2011) | Landmark Overall Survival at 6 Months | 47.9 Probability of event free at month 6 (%) |
| Part D (JTX-2011 + Nivolumab) | Landmark Overall Survival at 6 Months | 70.2 Probability of event free at month 6 (%) |
| Part E (JTX-2011 + Ipilimumab) | Landmark Overall Survival at 6 Months | 77.8 Probability of event free at month 6 (%) |
| Part G (JTX-2011 + Pembrolizumab) | Landmark Overall Survival at 6 Months | 66.7 Probability of event free at month 6 (%) |
Primary
Number of Participants With Dose Limiting Toxicities
Number of participants with at least one dose limiting toxicity (DLT)
Time frame: 33 months
Population: Part C and D did not have any participants analyzed for this outcome measure because DLT is only relevant to the Phase 1 parts of study (Part A, Part B, Part E and Part G).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A (JTX-2011) | Number of Participants With Dose Limiting Toxicities | 2 Participants |
| Part B (JTX-2011 + Nivolumab) | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part C (JTX-2011) | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part D (JTX-2011 + Nivolumab) | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part E (JTX-2011 + Ipilimumab) | Number of Participants With Dose Limiting Toxicities | 0 Participants |
| Part G (JTX-2011 + Pembrolizumab) | Number of Participants With Dose Limiting Toxicities | 0 Participants |
Primary
Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: 46.3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A (JTX-2011) | Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE) | 8 Participants |
| Part B (JTX-2011 + Nivolumab) | Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE) | 4 Participants |
| Part C (JTX-2011) | Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE) | 3 Participants |
| Part D (JTX-2011 + Nivolumab) | Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE) | 14 Participants |
| Part E (JTX-2011 + Ipilimumab) | Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE) | 0 Participants |
| Part G (JTX-2011 + Pembrolizumab) | Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE) | 0 Participants |
Primary
Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: 46.3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A (JTX-2011) | Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE) | 10 Participants |
| Part B (JTX-2011 + Nivolumab) | Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE) | 16 Participants |
| Part C (JTX-2011) | Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE) | 8 Participants |
| Part D (JTX-2011 + Nivolumab) | Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE) | 32 Participants |
| Part E (JTX-2011 + Ipilimumab) | Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE) | 5 Participants |
| Part G (JTX-2011 + Pembrolizumab) | Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE) | 3 Participants |
Primary
Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: 46.3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A (JTX-2011) | Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE) | 17 Participants |
| Part B (JTX-2011 + Nivolumab) | Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE) | 8 Participants |
| Part C (JTX-2011) | Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE) | 14 Participants |
| Part D (JTX-2011 + Nivolumab) | Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE) | 43 Participants |
| Part E (JTX-2011 + Ipilimumab) | Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE) | 4 Participants |
| Part G (JTX-2011 + Pembrolizumab) | Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE) | 2 Participants |
Primary
Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: 46.3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A (JTX-2011) | Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE) | 1 Participants |
| Part B (JTX-2011 + Nivolumab) | Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE) | 1 Participants |
| Part C (JTX-2011) | Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE) | 2 Participants |
| Part D (JTX-2011 + Nivolumab) | Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE) | 4 Participants |
| Part E (JTX-2011 + Ipilimumab) | Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE) | 2 Participants |
| Part G (JTX-2011 + Pembrolizumab) | Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE) | 0 Participants |
Primary
Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: 46.3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A (JTX-2011) | Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE) | 2 Participants |
| Part B (JTX-2011 + Nivolumab) | Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE) | 2 Participants |
| Part C (JTX-2011) | Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE) | 3 Participants |
| Part D (JTX-2011 + Nivolumab) | Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE) | 5 Participants |
| Part E (JTX-2011 + Ipilimumab) | Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE) | 0 Participants |
| Part G (JTX-2011 + Pembrolizumab) | Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE) | 1 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated
Time frame: 46.3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A (JTX-2011) | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 38 Participants |
| Part B (JTX-2011 + Nivolumab) | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 31 Participants |
| Part C (JTX-2011) | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 30 Participants |
| Part D (JTX-2011 + Nivolumab) | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 98 Participants |
| Part E (JTX-2011 + Ipilimumab) | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 11 Participants |
| Part G (JTX-2011 + Pembrolizumab) | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 6 Participants |
Primary
Overall Response Rate
Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review
Time frame: 46.5 months
Population: Response Evaluable Set: subjects who received any study drug and have a baseline tumor assessment, and either has at least one post-baseline tumor assessment scan and/or discontinued treatment due to death or disease progression The number of participants analyzed is zero for Part F and Part H because there were no participants enrolled in those two groups of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A (JTX-2011) | Overall Response Rate | 0 Participants |
| Part B (JTX-2011 + Nivolumab) | Overall Response Rate | 1 Participants |
| Part C (JTX-2011) | Overall Response Rate | 1 Participants |
| Part D (JTX-2011 + Nivolumab) | Overall Response Rate | 2 Participants |
| Part E (JTX-2011 + Ipilimumab) | Overall Response Rate | 0 Participants |
| Part G (JTX-2011 + Pembrolizumab) | Overall Response Rate | 0 Participants |
Primary
Overall Survival
The time from first dose date to the date of death for any cause
Time frame: 46.5 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A (JTX-2011) | Overall Survival | 7.6 months |
| Part B (JTX-2011 + Nivolumab) | Overall Survival | 8.9 months |
| Part C (JTX-2011) | Overall Survival | 4.9 months |
| Part D (JTX-2011 + Nivolumab) | Overall Survival | 9.5 months |
| Part E (JTX-2011 + Ipilimumab) | Overall Survival | 9.3 months |
| Part G (JTX-2011 + Pembrolizumab) | Overall Survival | 8.2 months |
Primary
Progression Free Survival
Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: 46.5 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A (JTX-2011) | Progression Free Survival | 2.1 months |
| Part B (JTX-2011 + Nivolumab) | Progression Free Survival | 2.0 months |
| Part C (JTX-2011) | Progression Free Survival | 1.9 months |
| Part D (JTX-2011 + Nivolumab) | Progression Free Survival | 2.0 months |
| Part E (JTX-2011 + Ipilimumab) | Progression Free Survival | 2.5 months |
| Part G (JTX-2011 + Pembrolizumab) | Progression Free Survival | 4.0 months |