Clear Cell Renal Cell Carcinoma (ccRCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
RCC, Melanoma (MEL), NSCLC, Immuno-Oncology, Tumor Metabolism, Glutaminase, Glutaminase Inhibitor
Brief summary
This study is an open-label Phase 1/2 evaluation of CB-839 in combination with nivolumab in participants with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.
Interventions
DRUGCB-839
Glutaminase inhibitor
DRUGNivolumab
PD-1 inhibitor
Sponsors
Calithera Biosciences, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Addition eligibility criteria based on tumor type apply Inclusion Criteria: * Ability to provide written informed consent in accordance with federal, local, and institutional guidelines * Histological or cytological diagnosis of metastatic cancer or locally advanced cancer that is not amenable to local therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Life Expectancy of at least 3 months * Adequate hepatic, renal, cardiac, and hematologic function * Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria * Resolution of treatment-related toxicities except alopecia
Exclusion criteria
* Unable to receive oral medications * Unable to receive oral or intravenous (IV) hydration * Intolerance to prior anti-PD-1/PD-L1 therapy * Prior severe hypersensitivity reaction to another monoclonal antibody (mAb) * Any other current or previous malignancy within 3 years except protocol allowed malignancies * Chemotherapy, TKI therapy, radiation therapy or hormonal therapy within 2 weeks * Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note: Some cohort exceptions allow anti-PD-1 therapy) * Active known or suspected exclusionary autoimmune disease * Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks * History of known risks factors for bowel perforation * Symptomatic ascites or pleural effusion * Major surgery within 28 days before Cycle 1 Day 1 * Active infection requiring parenteral antibiotics, antivirals, or antifungals within 2 weeks prior to first dose of study drug * Patients who have human immunodeficiency virus (HIV), Hepatitis B or C * Conditions that could interfere with treatment or protocol-related procedures * Active and/or untreated central nervous system (CNS) disease or non-stable brain metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | From the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days. | An adverse event (AE) is any untoward, undesired, or unplanned event that does not need to be causally related to treatment. A serious adverse event (SAE) is an AE that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in a persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, or important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based on appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Relatedness to study medication was graded as either, probably, possibly, unlikely, or unrelated. Events were categorized according to the Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. |
| Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | From the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days. | Hematology assessments included: hemoglobin; hematocrit, red blood cell count, white blood cell count with differential, and platelet count. Serum chemistry panel included: sodium, potassium, chloride, carbon dioxide, calcium, glucose, blood urea nitrogen, total protein, albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, creatinine, thyroid stimulating hormone. Vital sign assessments included systolic and diastolic blood pressures, pulse (heart) rate, respiratory rate, temperature, and body weight. |
| Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | up to a maximum of 2.8 years | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR or PR was required to be sustained for 4 weeks when confirmation was reported. * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Duration of Response (DOR) Per Investigator Assessed RECIST v1.1 | up to a maximum of 2.8 years | DOR is defined as the time between the first documentation of a PR or a CR to the first documentation of progressive disease (PD) or death, whichever occurred first. DOR was censored at the date of last radiographic disease if the patient was alive and progression free at the time of database lock, PD, or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol treatment prior to documentation of disease progression. * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) Per RECIST v1.1 | up to a maximum of 2.8 years | PFS was defined as time from the first dose date to the earlier of either PD per RECIST v1.1 or death from any cause. The duration of PFS was censored at the date of last radiographic disease if the patient was alive and progression-free at the time of analysis data cutoff, disease progression, or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol treatment prior to documentation of disease progression. \- PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Overall Survival | up to a maximum of 2.8 years | Overall survival was defined as the time from the first dose date to death due to any cause. For participants alive at time of analysis, overall survival was censored at the time when the participant was last known to be alive. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC. | 8 |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway. | 26 |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks. | 17 |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy. | 9 |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy. | 37 |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks. | 21 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 5 | 3 | 0 | 1 | 1 |
| Overall Study | Informed Consent Withdrawn | 0 | 0 | 1 | 0 | 1 | 1 |
| Overall Study | Investigator Decision | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Other, Not Specified | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Participant Request | 0 | 1 | 0 | 2 | 0 | 1 |
| Overall Study | Radiologic Disease Progression | 6 | 13 | 10 | 7 | 28 | 15 |
| Overall Study | Study Termination by Sponsor | 0 | 2 | 1 | 0 | 1 | 0 |
| Overall Study | Symptomatic Deterioration | 0 | 4 | 2 | 0 | 5 | 2 |
Baseline characteristics
| Characteristic | Telaglenastat 600 mg + Standard Dose Nivolumab | Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 13.51 | 58.4 years STANDARD_DEVIATION 10.75 | 67.8 years STANDARD_DEVIATION 9.85 | 63.2 years STANDARD_DEVIATION 7.9 | 63.4 years STANDARD_DEVIATION 11.82 | 67.0 years STANDARD_DEVIATION 11.55 | 63.3 years STANDARD_DEVIATION 11.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 23 Participants | 17 Participants | 9 Participants | 33 Participants | 20 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 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 | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 8 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) White | 8 Participants | 19 Participants | 16 Participants | 9 Participants | 34 Participants | 15 Participants | 101 Participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 3 Participants | 2 Participants | 15 Participants | 11 Participants | 42 Participants |
| Sex: Female, Male Male | 5 Participants | 18 Participants | 14 Participants | 7 Participants | 22 Participants | 10 Participants | 76 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 8 | 15 / 26 | 11 / 17 | 3 / 9 | 27 / 37 | 16 / 21 |
| other Total, other adverse events | 8 / 8 | 26 / 26 | 15 / 17 | 9 / 9 | 36 / 37 | 21 / 21 |
| serious Total, serious adverse events | 2 / 8 | 8 / 26 | 6 / 17 | 1 / 9 | 12 / 37 | 7 / 21 |
Outcome results
Primary
Duration of Response (DOR) Per Investigator Assessed RECIST v1.1
DOR is defined as the time between the first documentation of a PR or a CR to the first documentation of progressive disease (PD) or death, whichever occurred first. DOR was censored at the date of last radiographic disease if the patient was alive and progression free at the time of database lock, PD, or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol treatment prior to documentation of disease progression. * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: up to a maximum of 2.8 years
Population: Participants with a response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Duration of Response (DOR) Per Investigator Assessed RECIST v1.1 | 13.01 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Duration of Response (DOR) Per Investigator Assessed RECIST v1.1 | 3.71 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Duration of Response (DOR) Per Investigator Assessed RECIST v1.1 | 9.59 months |
Primary
Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight
Hematology assessments included: hemoglobin; hematocrit, red blood cell count, white blood cell count with differential, and platelet count. Serum chemistry panel included: sodium, potassium, chloride, carbon dioxide, calcium, glucose, blood urea nitrogen, total protein, albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, creatinine, thyroid stimulating hormone. Vital sign assessments included systolic and diastolic blood pressures, pulse (heart) rate, respiratory rate, temperature, and body weight.
Time frame: From the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Hematology Values | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Clinical Laboratory Values | 1 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Vital Sign Values | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Weight | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Vital Sign Values | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Clinical Laboratory Values | 4 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Hematology Values | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Weight | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Weight | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Vital Sign Values | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Clinical Laboratory Values | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Hematology Values | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Hematology Values | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Weight | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Clinical Laboratory Values | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Vital Sign Values | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Vital Sign Values | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Weight | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Clinical Laboratory Values | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Hematology Values | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Clinical Laboratory Values | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Vital Sign Values | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Weight | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight | Hematology Values | 1 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
An adverse event (AE) is any untoward, undesired, or unplanned event that does not need to be causally related to treatment. A serious adverse event (SAE) is an AE that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in a persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, or important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based on appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Relatedness to study medication was graded as either, probably, possibly, unlikely, or unrelated. Events were categorized according to the Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death.
Time frame: From the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab and telaglenastat | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to nivolumab | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab or telaglenastat dose interruption or reduction | 4 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to telaglenastat | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab dose interruption or reduction | 4 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to telaglenastat | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to nivolumab | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to nivolumab | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring telaglenastat dose interruption or reduction | 4 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to telaglenastat | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 | 5 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE | 8 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab and telaglenastat dose interruption or reduction | 3 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE | 2 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to telaglenastat | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to nivolumab | 6 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab or telaglenastat | 1 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 | 1 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to telaglenastat | 4 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE | 1 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to nivolumab | 0 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to discontinuation (DC) of nivolumab | 1 Participants |
| Telaglenastat 600 mg + Standard Dose Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab or telaglenastat | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to discontinuation (DC) of nivolumab | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab and telaglenastat dose interruption or reduction | 15 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of telaglenastat | 5 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to nivolumab | 22 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE | 26 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to telaglenastat | 24 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab dose interruption or reduction | 15 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab and telaglenastat | 4 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to nivolumab | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to nivolumab | 4 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring telaglenastat dose interruption or reduction | 16 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to telaglenastat | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to telaglenastat | 5 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 | 17 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to nivolumab | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to telaglenastat | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE | 7 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to nivolumab | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab or telaglenastat dose interruption or reduction | 16 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab or telaglenastat | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to nivolumab | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 | 8 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab and telaglenastat | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to nivolumab | 15 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab and telaglenastat dose interruption or reduction | 9 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to telaglenastat | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE | 17 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab or telaglenastat dose interruption or reduction | 10 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring telaglenastat dose interruption or reduction | 9 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to discontinuation (DC) of nivolumab | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to telaglenastat | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab dose interruption or reduction | 10 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to nivolumab | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 | 5 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of telaglenastat | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to nivolumab | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to telaglenastat | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to nivolumab | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to telaglenastat | 15 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab dose interruption or reduction | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE | 9 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 | 4 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to nivolumab | 8 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to telaglenastat | 9 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to nivolumab | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to telaglenastat | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to nivolumab | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to nivolumab | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to discontinuation (DC) of nivolumab | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring telaglenastat dose interruption or reduction | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab and telaglenastat dose interruption or reduction | 4 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab or telaglenastat dose interruption or reduction | 8 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to nivolumab | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab and telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab or telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 | 8 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to telaglenastat | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to nivolumab | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab dose interruption or reduction | 9 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to telaglenastat | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to nivolumab | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab or telaglenastat dose interruption or reduction | 15 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to nivolumab | 4 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE | 36 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to telaglenastat | 28 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE | 9 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to telaglenastat | 4 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab and telaglenastat | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to nivolumab | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 | 17 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring telaglenastat dose interruption or reduction | 14 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of telaglenastat | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab or telaglenastat | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to discontinuation (DC) of nivolumab | 1 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to nivolumab | 28 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab and telaglenastat dose interruption or reduction | 8 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring telaglenastat dose interruption or reduction | 10 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to telaglenastat | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE related to nivolumab | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 | 12 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab or telaglenastat dose interruption or reduction | 10 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to telaglenastat | 4 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 grade 5 TEAE | 0 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to telaglenastat | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 related to nivolumab | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE | 6 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE ≥ grade 3 related to nivolumab | 5 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to telaglenastat | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE ≥ grade 3 | 4 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab dose interruption or reduction | 5 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab or telaglenastat | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 serious TEAE related to nivolumab | 2 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to telaglenastat | 17 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE related to nivolumab | 17 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE | 21 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of telaglenastat | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to DC of nivolumab and telaglenastat | 3 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE requiring nivolumab and telaglenastat dose interruption or reduction | 5 Participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression) | ≥ 1 TEAE leading to discontinuation (DC) of nivolumab | 3 Participants |
Primary
Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR or PR was required to be sustained for 4 weeks when confirmation was reported. * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: up to a maximum of 2.8 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telaglenastat 600 mg + Standard Dose Nivolumab | Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 percentage of participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 24.0 percentage of participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 5.9 percentage of participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0 percentage of participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 5.4 percentage of participants |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 0.0 percentage of participants |
Secondary
Overall Survival
Overall survival was defined as the time from the first dose date to death due to any cause. For participants alive at time of analysis, overall survival was censored at the time when the participant was last known to be alive.
Time frame: up to a maximum of 2.8 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telaglenastat 600 mg + Standard Dose Nivolumab | Overall Survival | NA months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Overall Survival | 24.54 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Overall Survival | 22.57 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Overall Survival | NA months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Overall Survival | 10.91 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Overall Survival | 8.61 months |
Secondary
Progression-Free Survival (PFS) Per RECIST v1.1
PFS was defined as time from the first dose date to the earlier of either PD per RECIST v1.1 or death from any cause. The duration of PFS was censored at the date of last radiographic disease if the patient was alive and progression-free at the time of analysis data cutoff, disease progression, or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol treatment prior to documentation of disease progression. \- PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: up to a maximum of 2.8 years
Population: Participants with an event (PD per RECIST v1.1 or death from any cause).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telaglenastat 600 mg + Standard Dose Nivolumab | Progression-Free Survival (PFS) Per RECIST v1.1 | 3.42 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors | Progression-Free Survival (PFS) Per RECIST v1.1 | 3.72 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab | Progression-Free Survival (PFS) Per RECIST v1.1 | 3.71 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy | Progression-Free Survival (PFS) Per RECIST v1.1 | 1.87 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy | Progression-Free Survival (PFS) Per RECIST v1.1 | 2.07 months |
| Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy | Progression-Free Survival (PFS) Per RECIST v1.1 | 2.20 months |