A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types (CheckMate 76U)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Tumor

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04311710

CA209-76U

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 4 patient groups

Part 1 Arm A: mM, mUC, HCC

Experimental group

Description:

metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)

Treatment:

Drug: ipilimumab

Drug: nivolumab

Drug: ENHANZE (rHuPH20)

Drug: nivolumab

Part 1: Arm B: mM

Experimental group

Description:

metastatic Melanoma (mM)

Treatment:

Drug: ipilimumab

Drug: nivolumab

Drug: nivolumab

Part 2: Arm A: NSCLC

Experimental group

Description:

metastatic non small cell lung cancer (NSCLC)

Treatment:

Drug: ipilimumab

Drug: nivolumab

Drug: ENHANZE (rHuPH20)

Drug: nivolumab

Part 2: Arm B: RCC

Experimental group

Description:

advanced or metastatic renal cell carcinoma (RCC)

Treatment:

Drug: ipilimumab

Drug: nivolumab

Drug: ENHANZE (rHuPH20)

Drug: nivolumab