A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types
A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types
Checked against the public recordLast updated Feb 24, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: ipilimumab; Drug: nivolumab; Drug: ENHANZE (rHuPH20); Drug: nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Local Institution - 0020Hartford, Connecticut
- Local Institution - 0013Fort Wayne, Indiana
- Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapieNaples
- Humanitas-U.O di Oncologia medica ed EmatologiaRozzano
- ospedale le scotte-U.O.C. Immunoterapia OncologicaSiena
- Local Institution - 0010Auckland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 24, 2023. Always confirm current availability with the study team.