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  • NCT04311710

Active, Not Recruiting

A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types - CA209-76U

Oppdatert: 16 november, 2021   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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  • Phase 1/Phase 2

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • Active, Not Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Part 1 Arm A: mM, mUC, HCC
Experimental: Part 1: Arm B: mM
Drug: ipilimumab Drug: nivolumab
Experimental: Part 2: Arm A: NSCLC
Drug: ipilimumab Drug: ENHANZE (rHuPH20) Drug: nivolumab
Experimental: Part 2: Arm B: RCC
Drug: ipilimumab Drug: ENHANZE (rHuPH20) Drug: nivolumab

Nøkkelkriterier for kvalifikasjon

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.

Vi anbefaler at du kontakter BMS for å rapportere bivirkninger.
Bivirkninger (uønskede hendelser) og andre rapporterbare hendelser er definert her
For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046