Clinical trial NCT04311710: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tumor
Keywords: lung cancer, renal cancer, bladder cancer, skin cancer, liver cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-03-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)
timeFrame: Day 21
measure: Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)
timeFrame: Day 21
measure: Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)
timeFrame: Up to 21 days
measure: Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d)
timeFrame: Day 21
measure: Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
timeFrame: Up to 21 days
measure: Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)
timeFrame: Day 42
measure: Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)
timeFrame: Day 42
measure: Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)
timeFrame: Up to 42 days
measure: Part 2 Arm A: Observed concentration in ipilimumab (C42d)
timeFrame: Day 42
measure: Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)
timeFrame: Up to 42 days
measure: Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d)
timeFrame: Day 21
measure: Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)
timeFrame: Day 21
measure: Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax)
timeFrame: Up to 21 days
measure: Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d)
timeFrame: Day 21
measure: Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax)
timeFrame: Up to 21 days
Secondary outcomes:
measure: Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d)
timeFrame: Day 21
measure: Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d)
timeFrame: Day 21
measure: Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax)
timeFrame: Up to 21 days
measure: Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d)
timeFrame: Day 21
measure: Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax)
timeFrame: Up to 21 days
measure: Incidence of adverse events (AE's)
timeFrame: Up to 2.5 years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 5 years
measure: Incidence of AE's leading to discontinuation
timeFrame: Up to 2.5 years
measure: Incidence of death
timeFrame: Up to 2.5 years
measure: Incidence of laboratory abnormalities
timeFrame: Up to 2.5 years
measure: Instance of Anaphylactic occurring within 2 days of study drug administration
timeFrame: Up to 2.5 years
measure: Instance of hypersensitivity occurring within 2 days of study drug administration
timeFrame: Up to 2.5 years
measure: Incidence of hypersensitivity occurring within 2 days of study drug administration
timeFrame: Up to 2.5 years
measure: Incidence of infusion reactions occurring within 2 days of study drug administration
timeFrame: Up to 2.5 years
measure: Incidence of injection occurring within 2 days of study drug administration
timeFrame: Up to 2.5 years
measure: Percentage of participants who develop anti-ipilimumab antibodies
timeFrame: Up to 2.5 years
measure: Percentage of participants who develop anti-nivolumab antibodies
timeFrame: Up to 2.5 years
measure: Percentage of participants who have developed neutralizing antibodies
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Local Institution - 0020
state: Connecticut
city: Fort Wayne
country: United States
facility: Local Institution - 0013
state: Indiana
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
city: Rozzano
country: Italy
facility: Humanitas-U.O di Oncologia medica ed Ematologia
city: Siena
country: Italy
facility: ospedale le scotte-U.O.C. Immunoterapia Oncologica
city: Auckland
country: New Zealand
facility: Local Institution - 0010
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: