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

Stopped early · Phase 1

Conditions studied: Tumor

In brief

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

Key facts

Study ID

NCT04311710

Run by

Bristol-Myers Squibb

People needed

21

Starts

2020-06-25

Expected to finish

2023-01-18

Last updated by the study team

2023-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0020 — Hartford, Connecticut, United States
• Local Institution - 0013 — Fort Wayne, Indiana, United States
• Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie — Naples, Italy
• Humanitas-U.O di Oncologia medica ed Ematologia — Rozzano, Italy
• ospedale le scotte-U.O.C. Immunoterapia Oncologica — Siena, Italy
• Local Institution - 0010 — Auckland, New Zealand

Full record on ClinicalTrials.gov

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