Lung Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

21

Study ID:

NCT04311710

Recruitment Status:

Terminated

Sponsor:

Bristol-Myers Squibb

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There are 6 Locations for this study

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Local Institution - 0020
Hartford Connecticut, 06106, United States
Local Institution - 0013
Fort Wayne Indiana, 46804, United States
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
Napoli , 80131, Italy
Humanitas-U.O di Oncologia medica ed Ematologia
Rozzano , 20089, Italy
ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena , 53100, Italy
Local Institution - 0010
Auckland , 1023, New Zealand

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

21

Study ID:

NCT04311710

Recruitment Status:

Terminated

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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