TerminatedPhase 1NCT04311710

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

StatusTerminated
PhasePhase 1
U.S. locations6
SponsorBristol-Myers Squibb
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

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.

04
Study sites

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.

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