A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types
- Registration Number
- NCT04311710
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 21
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: Arm A: NSCLC ENHANZE (rHuPH20) metastatic non small cell lung cancer (NSCLC) Part 1 Arm A: mM, mUC, HCC ENHANZE (rHuPH20) metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC) Part 2: Arm B: RCC ENHANZE (rHuPH20) advanced or metastatic renal cell carcinoma (RCC) Part 1 Arm A: mM, mUC, HCC ipilimumab metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC) Part 1 Arm A: mM, mUC, HCC nivolumab metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC) Part 1: Arm B: mM ipilimumab metastatic Melanoma (mM) Part 1: Arm B: mM nivolumab metastatic Melanoma (mM) Part 2: Arm A: NSCLC nivolumab metastatic non small cell lung cancer (NSCLC) Part 2: Arm A: NSCLC ipilimumab metastatic non small cell lung cancer (NSCLC) Part 2: Arm B: RCC ipilimumab advanced or metastatic renal cell carcinoma (RCC) Part 2: Arm B: RCC nivolumab advanced or metastatic renal cell carcinoma (RCC)
- Primary Outcome Measures
Name Time Method Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax) Up to 21 days Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax) Up to 42 days Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d) Day 21 Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax) Up to 21 days Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax) Up to 42 days Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d) Day 21 Part 1 Arm A: Average concentration of ipilimumab (Cavg21d) Day 21 Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d) Day 21 Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d) Day 42 Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d) Day 21 Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax) Up to 21 days Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax) Up to 21 days Part 2 Arm A: Average concentration in ipilimumab (Cavg42d) Day 42 Part 2 Arm A: Observed concentration in ipilimumab (C42d) Day 42 Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d) Day 21
- Secondary Outcome Measures
Name Time Method Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax) Up to 21 days Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d) Day 21 Incidence of serious adverse events (SAEs) Up to 5 years Instance of Anaphylactic occurring within 2 days of study drug administration Up to 2.5 years Incidence of laboratory abnormalities Up to 2.5 years Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d) Day 21 Incidence of AE's leading to discontinuation Up to 2.5 years Instance of hypersensitivity occurring within 2 days of study drug administration Up to 2.5 years Incidence of infusion reactions occurring within 2 days of study drug administration Up to 2.5 years Percentage of participants who develop anti-nivolumab antibodies Up to 2.5 years Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax) Up to 21 days Incidence of hypersensitivity occurring within 2 days of study drug administration Up to 2.5 years Incidence of injection occurring within 2 days of study drug administration Up to 2.5 years Percentage of participants who have developed neutralizing antibodies Up to 2.5 years Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d) Day 21 Incidence of adverse events (AE's) Up to 2.5 years Incidence of death Up to 2.5 years Percentage of participants who develop anti-ipilimumab antibodies Up to 2.5 years
Trial Locations
- Locations (6)
Local Institution - 0010
🇳🇿Auckland, New Zealand
Local Institution - 0013
🇺🇸Fort Wayne, Indiana, United States
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
🇮🇹Napoli, Italy
Humanitas-U.O di Oncologia medica ed Ematologia
🇮🇹Rozzano, Italy
ospedale le scotte-U.O.C. Immunoterapia Oncologica
🇮🇹Siena, Italy
Local Institution - 0020
🇺🇸Hartford, Connecticut, United States