A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types
NCT ID: NCT04311710
Last Updated: 2023-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
21 participants
INTERVENTIONAL
2020-06-25
2023-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Arm A: mM, mUC, HCC
metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)
ipilimumab
Specified Dose on Specified Days
nivolumab
Specified Dose on Specified Days
ENHANZE (rHuPH20)
Specified Dose on Specified Days
Part 1: Arm B: mM
metastatic Melanoma (mM)
ipilimumab
Specified Dose on Specified Days
nivolumab
Specified Dose on Specified Days
Part 2: Arm A: NSCLC
metastatic non small cell lung cancer (NSCLC)
ipilimumab
Specified Dose on Specified Days
ENHANZE (rHuPH20)
Specified Dose on Specified Days
nivolumab
Specified Dose on Specified Days
Part 2: Arm B: RCC
advanced or metastatic renal cell carcinoma (RCC)
ipilimumab
Specified Dose on Specified Days
ENHANZE (rHuPH20)
Specified Dose on Specified Days
nivolumab
Specified Dose on Specified Days
Interventions
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ipilimumab
Specified Dose on Specified Days
nivolumab
Specified Dose on Specified Days
ENHANZE (rHuPH20)
Specified Dose on Specified Days
nivolumab
Specified Dose on Specified Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0020
Hartford, Connecticut, United States
Local Institution - 0013
Fort Wayne, Indiana, United States
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
Napoli, , Italy
Humanitas-U.O di Oncologia medica ed Ematologia
Rozzano, , Italy
ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena, , Italy
Local Institution - 0010
Auckland, , New Zealand
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-76U
Identifier Type: -
Identifier Source: org_study_id
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