Clinical Trials /

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

NCT04311710

Description:

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

Related Conditions:
  • Hepatocellular Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types
  • Official Title: A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab

Clinical Trial IDs

  • ORG STUDY ID: CA209-76U
  • NCT ID: NCT04311710

Conditions

  • Tumor

Interventions

DrugSynonymsArms
ipilimumab(BMS-734016)Part 1 Arm A: mM, mUC, HCC
nivolumab(BMS-936558)Part 1 Arm A: mM, mUC, HCC
ENHANZE (rHuPH20)Part 1 Arm A: mM, mUC, HCC
nivolumab(BMS-986298)Part 2: Arm A: NSCLC

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Part 1 Arm A: mM, mUC, HCCExperimentalmetastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)
  • ipilimumab
  • nivolumab
  • ENHANZE (rHuPH20)
Part 1: Arm B: mMExperimentalmetastatic Melanoma (mM)
  • ipilimumab
  • nivolumab
Part 2: Arm A: NSCLCExperimentalmetastatic non small cell lung cancer (NSCLC)
  • ipilimumab
  • ENHANZE (rHuPH20)
  • nivolumab
Part 2: Arm B: RCCExperimentaladvanced or metastatic renal cell carcinoma (RCC)
  • ipilimumab
  • ENHANZE (rHuPH20)
  • nivolumab

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)
Time Frame:Day 21
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d)
Time Frame:Day 21
Safety Issue:
Description:
Measure:Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d)
Time Frame:Day 21
Safety Issue:
Description:
Measure:Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax)
Time Frame:Up to 21 days
Safety Issue:
Description:
Measure:Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d)
Time Frame:Day 21
Safety Issue:
Description:
Measure:Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax)
Time Frame:Up to 21 days
Safety Issue:
Description:
Measure:Incidence of adverse events (AE's)
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of AE's leading to discontinuation
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Incidence of death
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Instance of Anaphylactic occurring within 2 days of study drug administration
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Instance of hypersensitivity occurring within 2 days of study drug administration
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Incidence of hypersensitivity occurring within 2 days of study drug administration
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Incidence of infusion reactions occurring within 2 days of study drug administration
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Incidence of injection occurring within 2 days of study drug administration
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Percentage of participants who develop anti-ipilimumab antibodies
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Percentage of participants who develop anti-nivolumab antibodies
Time Frame:Up to 2.5 years
Safety Issue:
Description:
Measure:Percentage of participants who have developed neutralizing antibodies
Time Frame:Up to 2.5 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • lung cancer, renal cancer, bladder cancer, skin cancer, liver cancer

Last Updated

March 23, 2020