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Clinical Trial NCT03899155 for Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Pan Tumor Rollover Study Phase 2 1,500
Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies
- CA209-8TT
- 2018-004362-34 (EudraCT Number)
pan-tumor
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalA1: Nivolumab Monotherapy Dose 1 | Nivolumab Specified dose on specified days |
ExperimentalA2: Nivolumab Monotherapy Dose 2 | Nivolumab Specified dose on specified days |
ExperimentalB1: Nivolumab + Ipilimumab | Nivolumab Specified dose on specified days Ipilimumab Specified dose on specified days |
ExperimentalB2: Nivolumab + Ipilimumab + Cabozantinib | Nivolumab Specified dose on specified days Ipilimumab Specified dose on specified days Cabozantinib Specified dose on specified days |
ExperimentalB3: Nivolumab + Ipilimumab + Trametinib | Nivolumab Specified dose on specified days Ipilimumab Specified dose on specified days Trametinib Specified dose on specified days |
ExperimentalC1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1 | Nivolumab + Relatlimab Specified dose on specified days |
ExperimentalC3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2 | Nivolumab + Relatlimab Specified dose on specified days |
ExperimentalC2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1 | Nivolumab Specified dose on specified days Relatlimab Specified dose on specified days |
ExperimentalC4: Relatlimab + Nivolumab SAV Dose 2 | Nivolumab Specified dose on specified days Relatlimab Specified dose on specified days |
ExperimentalC5: Relatlimab + Nivolumab + Ipilimumab | Nivolumab Specified dose on specified days Ipilimumab Specified dose on specified days |
ExperimentalC6: Relatlimab + Nivolumab + Capecitabine | Nivolumab + Relatlimab Specified dose on specified days Capecitabine Specified dose on specified days |
ExperimentalC7: Relatlimab + Nivolumab SAV Dose 3 | Nivolumab Specified dose on specified days Relatlimab Specified dose on specified days |
ExperimentalC10: Relatlimab + Nivolumab SAV Dose 4 | Nivolumab Specified dose on specified days Relatlimab Specified dose on specified days |
ExperimentalC12: Relatlimab + Nivolumab SAV Dose 5 | Nivolumab Specified dose on specified days Relatlimab Specified dose on specified days |
ExperimentalC8: Relatlimab + Nivolumab SAV + PDCT Dose 1 | Nivolumab Specified dose on specified days Relatlimab Specified dose on specified days |
ExperimentalC9: Relatlimab + Nivolumab SAV + Bevacizumab | Nivolumab Specified dose on specified days Relatlimab Specified dose on specified days Bevacizumab Specified dose on specified days |
ExperimentalC11: Relatlimab + Nivolumab SAV + PDCT Dose 2 | Nivolumab Specified dose on specified days Relatlimab Specified dose on specified days |
ExperimentalD1: Nivolumab + Temozolomide | Nivolumab Specified dose on specified days Temozolomide Specified dose on specified days |
ExperimentalD2: Nivolumab + Rucaparib | Nivolumab Specified dose on specified days Rucaparib Specified dose on specified days |
ExperimentalD3: Nivolumab + Daratumumab | Nivolumab Specified dose on specified days Daratumumab Specified dose on specified days |
ExperimentalD4: Nivolumab + Bevacizumab | Nivolumab Specified dose on specified days |
ExperimentalE1: Bevacizumab Monotherapy | Bevacizumab Specified dose on specified days |
ExperimentalE2: Regorafinib Monotherapy | Regorafinib Specified dose on specified days |
ExperimentalE4: Leucovorin + Oxaliplatin + Fluorouracil | Leucovorin Specified dose on specified days Fluorouracil Specified dose on specified days Oxaliplatin Specified dose on specified days |
ExperimentalE5: Enzalutamide Monotherapy | Enzalutamide Specified dose on specified days |
ExperimentalE6: Sunitinib Monotherapy | Sunitinib Specified dose on specified days |
ExperimentalE7: Rucaparib Monotherapy | Rucaparib Specified dose on specified days |
ExperimentalE8: Capecitabine Monotherapy | Capecitabine Specified dose on specified days |
ExperimentalE9: Cabozantinib Monotherapy | Cabozantinib Specified dose on specified days |
ExperimentalE10: Pemetrexed Monotherapy | Pemetrexed Specified dose on specified days |
ExperimentalE11: Pembrolizumab Monotherapy | Pembrolizumab Specified dose on specified days |
ExperimentalE3: Leucovorin + Fluorouracil | Leucovorin Specified dose on specified days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence of Adverse Events (AEs) | From Day 1 up to 135 Days after discontinuation of treatment | |
Incidence of drug related AEs | From Day 1 up to 135 Days after discontinuation of treatment | |
Incidence of AEs leading to Discontinuation | From Day 1 up to 135 Days after discontinuation of treatment | |
Incidence of Serious Adverse Events (SAEs) | From signature of Informed Consent up to 135 Days after discontinuation of treatment | |
Incidence of Select AEs | From Day 1 up to 135 Days after discontinuation of treatment | |
Incidence of Immune-Mediated AEs | From Day 1 up to 135 Days after discontinuation of treatment | |
Incidence of Death | From signature of Informed Consent up to 135 Days after discontinuation of treatment |
- Signed Written Informed Consent.
- Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.
- On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.
- WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.
- Participant is not eligible for study treatment per the Parent Study eligibility criteria.
- Participants not receiving clinical benefit as assessed by the Investigator.
- Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.
- Other protocol-defined Inclusion/Exclusion Criteria apply
New South Wales
Queensland
South Australia
Victoria
Western Australia
Alabama
Arizona
California
Colorado
Connecticut
District of Columbia
Florida
Illinois
Kansas
Kentucky
Maryland
Massachusetts
Michigan
Minnesota
Missouri
Nebraska
New Hampshire
New Mexico
New York
North Carolina
Ohio
Oklahoma
Pennsylvania
South Carolina
Tennessee
Texas
Utah
Virginia
Washington
Wisconsin
Buenos Aires
Córdoba Province
Río Negro Province
Santa Fe Province
Tucumán Province
Styria
Upper Austria
Minas Gerais
Rio Grande do Sul
São Paulo
Alberta
British Columbia
Nova Scotia
Ontario
Quebec
Región de la Araucanía
Santiago Metropolitan
Anhui
Beijing Municipality
Guangdong
Heilongjiang
Hunan
Jiangsu
Jilin
Shaanxi
Shanghai Municipality
Shanxi
Zhejiang
Gironde
Meurthe-Et-Moselle
Île-de-France Region
Baden-Wurttemberg
Bavaria
North Rhine-Westphalia
Attica
Crete
Heves County
Fc
MI
RM
Aomori
Chiba
Ehime
Fukuoka
Hyōgo
Ibaraki
Ishikawa-ken
Kanagawa
Miyagi
Niigata
Osaka
Shizuoka
Tokyo
Guanajuato
Jalisco
Mexico City
Michoacán
Nuevo León
Oaxaca
Querétaro
North Holland
Lima region
Kuyavian-Pomeranian Voivodeship
Warmian-Masurian Voivodeship
PR
Dolj
Sector 2
Krasnodarskiy Kray
Gyeonggi-do
Songpa-gu
Guipuzcoa
Madrid
Navarre
Greater London
Greater Manchester
Hampshire
Kent
Middlesex
Scotland