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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04311710
Phase
PHASE1
Status
Terminated

Conditions

  • Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab — DRUG
    Specified Dose on Specified Days
  • nivolumab — DRUG
    Specified Dose on Specified Days
  • ENHANZE (rHuPH20) — DRUG
    Specified Dose on Specified Days
  • nivolumab — DRUG
    Specified Dose on Specified Days

Study Details

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

Key Dates

Start date
Jun 25, 2020
Status verified
Feb 2023
Primary completion
Jan 14, 2021
Completion
Jan 18, 2023

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Arm A: mM, mUC, HCC
    metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)
  • Experimental: Part 1: Arm B: mM
    metastatic Melanoma (mM)
  • Experimental: Part 2: Arm A: NSCLC
    metastatic non small cell lung cancer (NSCLC)
  • Experimental: Part 2: Arm B: RCC
    advanced or metastatic renal cell carcinoma (RCC)

Primary Outcome Measure

Part 1 Arm A: Average concentration of ipilimumab (Cavg21d) [ Time Frame: Day 21 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Local Institution - 0020HartfordConnecticut06106-
Local Institution - 0013Fort WayneIndiana46804-

Find similar trials in Hartford, CT

By research site
Local Institution - 0020· Hartford, CTLocal Institution - 0013· Fort Wayne, IN

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