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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedipilimumab and nivolumab

Plus 2 other study approaches.

Who it may be forTumor

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 24, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

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

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How this study is categorized

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

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
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%

Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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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