Renal Cell Carcinoma
Conditions
Brief summary
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.
Interventions
BIOLOGICALNivolumab
Specific dose on specific days
BIOLOGICALIpilimumab
Specific dose on specific days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Participants and Target Disease Characteristics- - * Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab * Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be submitted for embedded tissue block or tumor tissue. Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection. WOCBP need to use contraception throughout the study and for 5 months post treatment.
Exclusion criteria
autoimmune disease statement * Active central nervous system metastases * Participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll. * Any major surgery 28 days before 1st treatment Concomitant Therapy * participants that have received a live vaccine within 30 days of treatment. * use of investigational agent or device with in 28 days before first dosage study treatment. Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and Reproduction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | From first dose up to approximately 14 months | Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months) | Overall Response Rate (ORR) is defined as the percentage of participants who achieve a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (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) | From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months) | Duration of Response (DOR) is defined as the time between the date of first documented response (complete response (CR) or partial response (PR)) to the date of the first documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Overall Survival (OS) | From first dose to the date of death from any cause (up to approximately 14 months) | Overall Survival (OS) is defined as the time from first dose to the date of death from any cause. For participants that are alive, their survival time will be censored at the date of last contact (last known alive date). OS will be censored for participants at the date of first dose if they were treated but had no follow-up. |
| Time to Objective Response (TTR) | From first dose to the first confirmed documented response (up to approximately 14 months) | Time to Objective Response (TTR) is defined as the time between the date of the first dose and the first confirmed documented response (complete response (CR) or partial response (PR)) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| The Number of Participants Experiencing Adverse Events (AEs) | From first dose and 100 days after lost dose (up to approximately 14 months) | The number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. |
| Progression Free Survival (PFS) | From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months) | Progression Free Survival (PFS) is defined as the time between the date of first dose and the first date of documented progression, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NIVO 3 + IPI 1 Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W). | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease progression | 3 |
| Overall Study | Participant withdrew consent | 1 |
| Overall Study | Reason unknown | 1 |
Baseline characteristics
| Characteristic | NIVO 3 + IPI 1 |
|---|---|
| Age, Continuous | 62.2 Years STANDARD_DEVIATION 11 |
| Age, Customized >= 65 AND < 75 years | 3 Participants |
| Age, Customized < 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 2 / 5 |
Outcome results
Primary
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Time frame: From first dose up to approximately 14 months
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NIVO 3 + IPI 1 | Disease Control Rate (DCR) | 60.0 Percentage of participants |
Secondary
Duration of Response (DOR)
Duration of Response (DOR) is defined as the time between the date of first documented response (complete response (CR) or partial response (PR)) to the date of the first documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Population: All treated participants with CR or PR
Secondary
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the percentage of participants who achieve a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months)
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NIVO 3 + IPI 1 | Overall Response Rate (ORR) | 0.0 Percentage of participants |
Secondary
Overall Survival (OS)
Overall Survival (OS) is defined as the time from first dose to the date of death from any cause. For participants that are alive, their survival time will be censored at the date of last contact (last known alive date). OS will be censored for participants at the date of first dose if they were treated but had no follow-up.
Time frame: From first dose to the date of death from any cause (up to approximately 14 months)
Population: All treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NIVO 3 + IPI 1 | Overall Survival (OS) | NA Months |
Secondary
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time between the date of first dose and the first date of documented progression, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Population: All treated participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NIVO 3 + IPI 1 | Progression Free Survival (PFS) | NA Months |
Secondary
The Number of Participants Experiencing Adverse Events (AEs)
The number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose and 100 days after lost dose (up to approximately 14 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIVO 3 + IPI 1 | The Number of Participants Experiencing Adverse Events (AEs) | 5 Participants |
Secondary
Time to Objective Response (TTR)
Time to Objective Response (TTR) is defined as the time between the date of the first dose and the first confirmed documented response (complete response (CR) or partial response (PR)) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose to the first confirmed documented response (up to approximately 14 months)
Population: All treated participants with CR or PR