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A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types (CheckMate 76U)

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ClinicalTrials.gov Identifier: NCT04311710
Recruitment Status : Active, not recruiting
First Posted : March 17, 2020
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Tumor Drug: ipilimumab Drug: nivolumab Drug: ENHANZE (rHuPH20) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab
Actual Study Start Date : June 25, 2020
Actual Primary Completion Date : January 14, 2021
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1 Arm A: mM, mUC, HCC
metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)
Drug: ipilimumab
Specified Dose on Specified Days
Other Name: (BMS-734016)

Drug: nivolumab
Specified Dose on Specified Days
Other Name: (BMS-936558)

Drug: ENHANZE (rHuPH20)
Specified Dose on Specified Days

Experimental: Part 1: Arm B: mM
metastatic Melanoma (mM)
Drug: ipilimumab
Specified Dose on Specified Days
Other Name: (BMS-734016)

Drug: nivolumab
Specified Dose on Specified Days
Other Name: (BMS-936558)

Experimental: Part 2: Arm A: NSCLC
metastatic non small cell lung cancer (NSCLC)
Drug: ipilimumab
Specified Dose on Specified Days
Other Name: (BMS-734016)

Drug: ENHANZE (rHuPH20)
Specified Dose on Specified Days

Drug: nivolumab
Specified Dose on Specified Days
Other Name: (BMS-986298)

Experimental: Part 2: Arm B: RCC
advanced or metastatic renal cell carcinoma (RCC)
Drug: ipilimumab
Specified Dose on Specified Days
Other Name: (BMS-734016)

Drug: ENHANZE (rHuPH20)
Specified Dose on Specified Days

Drug: nivolumab
Specified Dose on Specified Days
Other Name: (BMS-986298)




Primary Outcome Measures :
  1. Part 1 Arm A: Average concentration of ipilimumab (Cavg21d) [ Time Frame: Day 21 ]
  2. Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d) [ Time Frame: Day 21 ]
  3. Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax) [ Time Frame: Up to 21 days ]
  4. Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d) [ Time Frame: Day 21 ]
  5. Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax) [ Time Frame: Up to 21 days ]
  6. Part 2 Arm A: Average concentration in ipilimumab (Cavg42d) [ Time Frame: Day 42 ]
  7. Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d) [ Time Frame: Day 42 ]
  8. Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax) [ Time Frame: Up to 42 days ]
  9. Part 2 Arm A: Observed concentration in ipilimumab (C42d) [ Time Frame: Day 42 ]
  10. Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax) [ Time Frame: Up to 42 days ]
  11. Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d) [ Time Frame: Day 21 ]
  12. Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d) [ Time Frame: Day 21 ]
  13. Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax) [ Time Frame: Up to 21 days ]
  14. Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d) [ Time Frame: Day 21 ]
  15. Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax) [ Time Frame: Up to 21 days ]

Secondary Outcome Measures :
  1. Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d) [ Time Frame: Day 21 ]
  2. Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d) [ Time Frame: Day 21 ]
  3. Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax) [ Time Frame: Up to 21 days ]
  4. Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d) [ Time Frame: Day 21 ]
  5. Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax) [ Time Frame: Up to 21 days ]
  6. Incidence of adverse events (AE's) [ Time Frame: Up to 2.5 years ]
  7. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 5 years ]
  8. Incidence of AE's leading to discontinuation [ Time Frame: Up to 2.5 years ]
  9. Incidence of death [ Time Frame: Up to 2.5 years ]
  10. Incidence of laboratory abnormalities [ Time Frame: Up to 2.5 years ]
  11. Instance of Anaphylactic occurring within 2 days of study drug administration [ Time Frame: Up to 2.5 years ]
  12. Instance of hypersensitivity occurring within 2 days of study drug administration [ Time Frame: Up to 2.5 years ]
  13. Incidence of hypersensitivity occurring within 2 days of study drug administration [ Time Frame: Up to 2.5 years ]
  14. Incidence of infusion reactions occurring within 2 days of study drug administration [ Time Frame: Up to 2.5 years ]
  15. Incidence of injection occurring within 2 days of study drug administration [ Time Frame: Up to 2.5 years ]
  16. Percentage of participants who develop anti-ipilimumab antibodies [ Time Frame: Up to 2.5 years ]
  17. Percentage of participants who develop anti-nivolumab antibodies [ Time Frame: Up to 2.5 years ]
  18. Percentage of participants who have developed neutralizing antibodies [ Time Frame: Up to 2.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311710


Locations
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
United States, Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46804
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
Napoli, Italy, 80131
Humanitas-U.O di Oncologia medica ed Ematologia
Rozzano, Italy, 20089
ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena, Italy, 53100
New Zealand
Local Institution
Auckland, New Zealand, 1023
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04311710    
Other Study ID Numbers: CA209-76U
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
lung cancer, renal cancer, bladder cancer, skin cancer, liver cancer
Additional relevant MeSH terms:
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Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents