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Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma

Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…

A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma

This study has been transitioned to CTIS with ID 2022-500630-29-00 check the CTIS register for the current data. We hypothesise that treatment with nivolumab will extend disease-free survival, compared with placebo, as adjuvant therapy in all…

A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in combination with Ipilimumab placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The aim of the study is to compare the Overall Response Rate (ORR) and assess Duration of Response (DoR) of the treatment of nivolumab in combination with ipilumumab vs. nivolumab in combination with ipilimumab placebo, as determined by a blinded…

A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo as Maintenance Therapy in Subjects with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) after Completion of Platinum-based First Line Chemotherapy

The aim of the study is to compare overall survival (OS) and Blinded Independent Central Review (BICR)-assessed progression free survival (PFS), of nivolumab, and nivolumab in combination with ipilimumab, versus placebo in subjects with ED-SCLC…

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CA209-76K)

This study has been transitioned to CTIS with ID 2022-502354-14-00 check the CTIS register for the current data. Primary Objective:To measure the efficacy provided by nivolumab therapy on its own compared to placebo in participants who have had…

A phase Ib/II randomized double-blind placebo controlled trial evaluating the effect of Nivolumab for patients with in-transit melanoma metastases treated with isolated limb perfusion (NivoILP trial)

This study has been transitioned to CTIS with ID 2023-509265-21-00 check the CTIS register for the current data. To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further…

A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Subjects with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

The objective of this study is to evaluate the efficacy and safety of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in previously untreated subjects with intermediate- and poor-risk advanced or metastatic…

A phase 3, randomized, double-blind trial of nivolumab in combination with intravesical BCG versus standard of care BCG alone in participants with high-risk non-muscle invasive bladder cancer that is persistent or recurrent after treatment with BCG

Primary objectiveTo compare the event free survival per pathological review committee (PRC) of nivolumab plus BCG vs BCG alone in all randomized ParticipantsEFS, defined as the time from randomization until any of the following events: recurrence (…

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer

This study has been transitioned to CTIS with ID 2023-509360-24-00 check the CTIS register for the current data. Primary objectives: This study has co-primary objectives:• To compare OS of nivolumab versus placebo in subjects with resected EC or GEJ…

A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab
Combined with Ipilimumab vs Placebo in Participants with Localized Renal Cell Carcinoma
Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

Primary ObjectivePart A: To compare disease-free survival (DFS) per Blinded Independent Central Review (BICR) of nivolumab combined with ipilimumab versus placebo infusions in participants with localized RCC, with a predominantly clear cell…

A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Versus Ipilimumab Monotherapy in Subjects with Previously Untreated Unresectable or Metastatic Melanoma

Primary Objectives - To compare Overall Survival (OS) and Progression free survival (PFS) of nivolumab monotherapy to ipilimumab monotherapy and that of nivolumab combined with ipilimumab to ipilimumab monotherapy in subjects with previously…

A Phase 3, Randomized, Double blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer

This study has been transitioned to CTIS with ID 2022-502658-15-00 check the CTIS register for the current data. Primary Objective• To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A (vs Arm B…

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab versus Placebo for
Participants with Hepatocellular Carcinoma Who Are at High Risk of Recurrence after Curative
Hepatic Resection or Ablation

This study has been transitioned to CTIS with ID 2023-508726-10-00 check the CTIS register for the current data. Objectives of the studyPrimary ObjectiveTo compare recurrence-free survival (RFS)(based on BICR assessment) of nivolumab versus placebo…