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

Phase 1TerminatedNCT04311710

Bristol-Myers Squibb21 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tumor

Interventions

ipilimumabDRUG

Specified Dose on Specified Days

nivolumabDRUG

Specified Dose on Specified Days

ENHANZE (rHuPH20)DRUG

Specified Dose on Specified Days

nivolumab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

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

Naples, Italy

Humanitas-U.O di Oncologia medica ed Ematologia

Rozzano, Italy

Outcomes

Primary Outcomes

Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)

Time frame: Day 21

Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)

Time frame: Day 21

Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)

Time frame: Up to 21 days

Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d)

Time frame: Day 21

Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)

Time frame: Up to 21 days

Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)

Time frame: Day 42

Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)

Time frame: Day 42

Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)

Time frame: Up to 42 days

Part 2 Arm A: Observed concentration in ipilimumab (C42d)

Time frame: Day 42

Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)

Time frame: Up to 42 days

Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d)

Time frame: Day 21

Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d)

Time frame: Day 21

Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d)

Time frame: Day 21

Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax)

Time frame: Up to 21 days

Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d)

Time frame: Day 21

Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax)

Time frame: Up to 21 days

Incidence of adverse events (AE's)

Time frame: Up to 2.5 years

Incidence of serious adverse events (SAEs)

Time frame: Up to 5 years

Incidence of AE's leading to discontinuation

Time frame: Up to 2.5 years

Incidence of death

Time frame: Up to 2.5 years

Incidence of laboratory abnormalities

Time frame: Up to 2.5 years

Instance of Anaphylactic occurring within 2 days of study drug administration

Time frame: Up to 2.5 years

Instance of hypersensitivity occurring within 2 days of study drug administration

Time frame: Up to 2.5 years

Incidence of hypersensitivity occurring within 2 days of study drug administration

Time frame: Up to 2.5 years

Incidence of infusion reactions occurring within 2 days of study drug administration

Time frame: Up to 2.5 years

Incidence of injection occurring within 2 days of study drug administration

Time frame: Up to 2.5 years

Percentage of participants who develop anti-ipilimumab antibodies

Time frame: Up to 2.5 years

Percentage of participants who develop anti-nivolumab antibodies

Time frame: Up to 2.5 years

Percentage of participants who have developed neutralizing antibodies

Time frame: Up to 2.5 years