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

Phase 1

• Conditions: The study population will include participants diagnosed with metastatic melanoma, advanced/metastatic urothelial carcinoma (mUC), advanced hepatocellular carcinoma (HCC) in Part 1, and metastatic squamous or non-squamous non-small cell lung cancer (NSCLC), and metastatic renal cell carcinoma (RCC) in Part 2.; MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004380-40-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-23
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 81

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%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

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 co-infection 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified