Clinical Trial: NCT04311710 - My Cancer Genome

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:

Active, not recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04311710

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

Drug	Synonyms	Arms
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

Name	Type	Description	Interventions
Part 1 Arm A: mM, mUC, HCC	Experimental	metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)	ipilimumab nivolumab ENHANZE (rHuPH20)
Part 1: Arm B: mM	Experimental	metastatic Melanoma (mM)	ipilimumab nivolumab
Part 2: Arm A: NSCLC	Experimental	metastatic non small cell lung cancer (NSCLC)	ipilimumab ENHANZE (rHuPH20) nivolumab
Part 2: Arm B: RCC	Experimental	advanced 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:	Active, not recruiting
Lead Sponsor:	Bristol-Myers Squibb

Trial Keywords

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

Last Updated

May 27, 2021

Clinical Trials /

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