Active, Not Recruiting

Trial ID CA209-76U | NCT04311710

A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types

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About This Trial
Key Eligibility Criteria

Summary

Phase 1
18+

Age Range
Active, Not Recruiting

Overview

A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Men and women must follow methods of contraception as described in the protocol Part 1 Arms A and B: Metastatic Melanoma - Previously untreated, histologically confirmed stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system v.8.0 Part 1 Arm A:Advanced/mUC - Participants with histologically or cytologically confirmed urothelial carcinoma. Part 1 Arm A: Advanced HCC - Participants with histological confirmation of Hepatocellular Cancer (HCC) Part 2 Arm A: Metastatic NSCLC - Participants with histologically confirmed stage IV or recurrent Non Small Cell Lung Cancer (NSCLC) Part 2 Arm B: Advanced or Metastatic RCC - Histological confirmation of Renal Cell Carcinoma (RCC) - ECOG Performance Status of 0 or 1 and for RCC (Part 2 Arm B), Karnofsky performance status ≥ 70% Exclusion Criteria: - History of allergy or hypersensitivity to study drug components Part 1 Arm A: Advanced HCC - History of hepatic encephalopathy or evidence of portal hypertension - Active coinfection with hepatitis D virus infection in participants with HBV Part 2 Arm A:Metastatic NSCLC - Participants with known ALK translocations and EGFR mutation that are sensitive to available targeted inhibitor therapy Other inclusion/exclusion criteria apply.

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part 1 Arm A: mM, mUC, HCC

ASSIGNED INTERVENTION

Study Arms

Experimental: Part 1: Arm B: mM

ASSIGNED INTERVENTION

Drug: nivolumab Drug: ipilimumab

Study Arms

Experimental: Part 2: Arm A: NSCLC

ASSIGNED INTERVENTION

Drug: ipilimumab Drug: nivolumab Drug: ENHANZE (rHuPH20)

Study Arms

Experimental: Part 2: Arm B: RCC

ASSIGNED INTERVENTION

Drug: ipilimumab Drug: nivolumab Drug: ENHANZE (rHuPH20)