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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 : Recruiting
First Posted : March 17, 2020
Last Update Posted : October 27, 2020
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)
Estimated Enrollment : 81 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 22, 2020
Estimated Primary Completion Date : March 17, 2024
Estimated Study Completion Date : October 7, 2025

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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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United States, California
Local Institution Not yet recruiting
San Francisco, California, United States, 94158
Contact: Site 0001         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Omar Eton, Site 0020    860-972-5371      
United States, Indiana
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Sunil Babu, Site 0013    260-436-0800      
Australia, Victoria
Local Institution Not yet recruiting
Malvern, Victoria, Australia, 3144
Contact: Site 0008         
Brazil
Local Institution Not yet recruiting
S?o Paulo, SAO Paulo, Brazil, 05653120
Contact: Site 0022         
Local Institution Not yet recruiting
Sao Paulo, Brazil, 01246000
Contact: Site 0021         
France
Local Institution Not yet recruiting
Lyon, France, 69008
Contact: Site 0012         
Local Institution Not yet recruiting
Marseille, France, 13385
Contact: Site 0014         
Local Institution Not yet recruiting
Saint Herblain, France, 44805
Contact: Site 0011         
Local Institution Not yet recruiting
Toulouse, France, 31059
Contact: Site 0019         
Italy
Local Institution Not yet recruiting
Milano, Italy, 20133
Contact: Site 0003         
Local Institution Not yet recruiting
Napoli, Italy, 80131
Contact: Site 0002         
Humanitas-U.O di Oncologia medica ed Ematologia Recruiting
Rozzano, Italy, 20089
Contact: Matteo Simonelli, Site 0004    +39022244559      
ospedale le scotte-U.O.C. Immunoterapia Oncologica Recruiting
Siena, Italy, 53100
Contact: Michele Maio, Site 0005    +390577586335 0000 000000      
Netherlands
Local Institution Not yet recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Site 0023         
New Zealand
Local Institution Recruiting
Auckland, New Zealand, 1023
Contact: Site 0010         
Spain
Local Institution Not yet recruiting
Madrid, Spain, 28050
Contact: Site 0027         
Local Institution Not yet recruiting
Pamplona, Spain, 31008
Contact: Site 0026         
United Kingdom
Local Institution Not yet recruiting
Liverpool, United Kingdom, L7 8YA
Contact: Site 0028         
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: October 27, 2020
Last Verified: October 2020

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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