Health Condition 1: C790- Secondary malignant neoplasm of kidney and renal pelvis
Conditions
Interventions
Intervention1: Nivolumab in Combination with Ipilimumab: Participants will receive a combination dosing regimen of nivolumab 3 mg/kg as a 30-minute IV
infusion + ipilimumab 1 mg/kg as a 30-minute IV i
Sponsors
BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent a) Participants must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocolrelated procedures that are not part of normal participant care. b) Participants must be willing and able to comply with scheduled visits, treatment schedule,laboratory tests, biomarker and PK testing, and other requirements of the study. 2) Type of Participant and Target Disease Characteristics a) Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features. Advanced (not amenable to curative surgery or radiation therapy) RCC or mRCC. b) No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resected RCC 2b). These drugs must be discontinued ï?³ï? 6 months prior to study entry. All AEs related to prior adjuvant or neoadjuvant therapy must have returned to baseline, and eligible patients must not have experienced severe or life-threatening immune-related AEs except those that are unlikely to reoccur with standard countermeasures (eg, hormone replacement after adrenal crisis). c) Measurable disease lesion by CT or MRI per RECIST 1.1 criteria. Radiated lesions cannot be used as measurable lesions unless there is clear evidence of progression. d) KPS of at least 70% e) Qualifies as intermediate or poor risk by meeting least 1 of the following prognostic factors as per the IMDC criteria: i) KPS less than 80 ii) Less than 1 year from diagnosis including original localized disease (if applicable) to study enrollment iii) Hemoglobin less than the lower limit of normal iv) Corrected calcium concentration greater than 10 mg/dL. v) Absolute neutrophil count greater than the ULN vi) Platelet count greater than the ULN 3) Age and Reproductive Status a) Male and female participants must be 18 years or older at the time of informed consent(ICF) b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human horionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment. c) Women must not be breastfeeding. d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment plus 5 half-lives of study treatment plus 30 days (duration of ovulatory cycle) for a total of 5 months after the last dose of study treatment. e) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception and fetal protection (Appendix 4) for the duration of treatment with nivolumab and ipilimumab plus 7 months after the last dose of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time. f) WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section. g) Azoospermic males are exempt from contraceptive requirements unless the potential exists for fetal toxicity due to study drug being present in seminal fluid, even if the part
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the incidence of high-grade (CTCAE v5 Grade 3 to 4 and Grade 5) IMAEs in intermediateor poor-risk participants with previously untreated, advanced RCC who are treated with combination therapy of nivolumab 3 mg/kg administered intravenously over a period of 30 minutes Q3W for the first 4 doses in combination with intravenous ipilimumab 1 mg/kg over a period of 30 minutes, followed by nivolumab 3 mg/kg Q2W administered IV over a period of 30 minutesTimepoint: To assess the incidence of high-grade (CTCAE v5 Grade 3 to 4 and Grade 5) IMAEs in intermediateor poor-risk participants with previously untreated, advanced RCC who are treated with combination therapy of nivolumab 3 mg/kg administered intravenously over a period of 30 minutes Q3W for the first 4 doses in combination with intravenous ipilimumab 1 mg/kg over a period of 30 minutes, followed by nivolumab 3 mg/kg Q2W administered IV over a period of 30 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of nivolumab in combination with ipilimumab by measuring ORR, TTR, and DOR, using RECIST 1.1.Timepoint: Every 8 weeks;To characterize the outcome of all high grade (CTCAE v5 Grade 3 to 4 and Grade 5) IMAEs in intermediate or poor risk participants with previously untreated, advanced RCC.Timepoint: EVERY 8 WEEKS | — |
Countries
India
Contacts
Public ContactShilpi Sinha
Bristol Myers Squibb India Pvt. Ltd.
Outcome results
None listed