Status:
TERMINATED
A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types
Eligibility Criteria
Inclusion
- 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%
Exclusion
- \- 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.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04311710
Start Date
June 25 2020
End Date
January 18 2023
Last Update
February 24 2023
Active Locations (6)
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1
Local Institution - 0020
Hartford, Connecticut, United States, 06106
2
Local Institution - 0013
Fort Wayne, Indiana, United States, 46804
3
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
Napoli, Italy, 80131
4
Humanitas-U.O di Oncologia medica ed Ematologia
Rozzano, Italy, 20089