Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029270
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-09-07
Brief Title:
Testing the Addition of BMS-986016 Relatlimab to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 Relatlimab as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated RecurrentMetastatic Nasopharyngeal Carcinoma REMAIN
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests the addition of BMS-986016 relatlimab to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement recurrent or that has spread from where it first started primary site to other places in the body metastatic Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin or carboplatin and gemcitabine along with immunotherapy such as nivolumab After the initial treatment is finished patients may continue to receive additional immunotherapy Carboplatin is in a class of medications known as platinum-containing compounds It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin Carboplatin works by killing stopping or slowing the growth of tumor cells Immunotherapy with monoclonal antibodies such as nivolumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid DNA and may kill cancer cells Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine if adding BMS-986016 relatlimab to nivolumab maintenance therapy shows a signal of improved progression-free survival PFS according to Response Evaluation Criteria in Solid Tumors RECIST 11 in patients who do not progress following treatment with platinum-gemcitabine-nivolumab combination in the first-line treatment of recurrent andor metastatic nasopharyngeal carcinoma RM NPC
SECONDARY OBJECTIVES
I To determine if adding BMS-986016 relatlimab to nivolumab maintenance improves overall survival OS compared to nivolumab maintenance alone
II To compare patterns of failure local-regional relapse and distant metastasis between treatment arms
III To determine if adding BMS-986016 relatlimab to nivolumab maintenance improves objective response duration of response and disease control rate compared to nivolumab maintenance alone
IV To evaluate the tolerability of nivolumab-BMS-986016 relatlimab maintenance and assess and compare toxicity between arms based on the Common Terminology Criteria for Adverse Events version 50 CTCAE v50 criteria
V To evaluate baseline plasma Epstein-Barr virus EBV DNA 2000 copiesmL versus vs 2000 copiesmL as a prognostic biomarker
VI To validate post-induction plasma EBV DNA detectable 1 copiesmL vs undetectable 0 copiesmL as a prognostic biomarker
EXPLORATORY OBJECTIVES
I To collect blood and tissue specimens for future translational science studies
II To assess post-induction plasma EBV DNA detectable 1 copiesmL vs undetectable 0 copiesmL as a predictive biomarker
OUTLINE
INDUCTION THERAPY Patients receive nivolumab intravenously IV over 30 minutes on day 1 of each cycle cisplatin IV or carboplatin IV over 30-60 minutes on day 1 of each cycle and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT or magnetic resonance imaging MRI and blood sample collection during screening and on study
MAINTENANCE THERAPY Patients who do not progress radiologically are randomized to 1 of 2 arms
ARM I Patients receive nivolumab IV over 30 minutes Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity Patients undergo CT or MRI on study Patients also undergo positron emission tomography PETCT or bone scan as clinically indicated
ARM II Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30-90 minutes Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity Patients undergo CT or MRI on study Patients also undergo PETCT or bone scan as clinically indicated
After completion of study treatment patients are followed up every 4 months for 2 years every 6 months in years 3-5 and then annually
I To determine if adding BMS-986016 relatlimab to nivolumab maintenance therapy shows a signal of improved progression-free survival PFS according to Response Evaluation Criteria in Solid Tumors RECIST 11 in patients who do not progress following treatment with platinum-gemcitabine-nivolumab combination in the first-line treatment of recurrent andor metastatic nasopharyngeal carcinoma RM NPC
SECONDARY OBJECTIVES
I To determine if adding BMS-986016 relatlimab to nivolumab maintenance improves overall survival OS compared to nivolumab maintenance alone
II To compare patterns of failure local-regional relapse and distant metastasis between treatment arms
III To determine if adding BMS-986016 relatlimab to nivolumab maintenance improves objective response duration of response and disease control rate compared to nivolumab maintenance alone
IV To evaluate the tolerability of nivolumab-BMS-986016 relatlimab maintenance and assess and compare toxicity between arms based on the Common Terminology Criteria for Adverse Events version 50 CTCAE v50 criteria
V To evaluate baseline plasma Epstein-Barr virus EBV DNA 2000 copiesmL versus vs 2000 copiesmL as a prognostic biomarker
VI To validate post-induction plasma EBV DNA detectable 1 copiesmL vs undetectable 0 copiesmL as a prognostic biomarker
EXPLORATORY OBJECTIVES
I To collect blood and tissue specimens for future translational science studies
II To assess post-induction plasma EBV DNA detectable 1 copiesmL vs undetectable 0 copiesmL as a predictive biomarker
OUTLINE
INDUCTION THERAPY Patients receive nivolumab intravenously IV over 30 minutes on day 1 of each cycle cisplatin IV or carboplatin IV over 30-60 minutes on day 1 of each cycle and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT or magnetic resonance imaging MRI and blood sample collection during screening and on study
MAINTENANCE THERAPY Patients who do not progress radiologically are randomized to 1 of 2 arms
ARM I Patients receive nivolumab IV over 30 minutes Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity Patients undergo CT or MRI on study Patients also undergo positron emission tomography PETCT or bone scan as clinically indicated
ARM II Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30-90 minutes Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity Patients undergo CT or MRI on study Patients also undergo PETCT or bone scan as clinically indicated
After completion of study treatment patients are followed up every 4 months for 2 years every 6 months in years 3-5 and then annually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-06678 | REGISTRY | None | None |
| NRG-HN011 | OTHER | None | None |
| NRG-HN011 | OTHER | None | None |
| U10CA180868 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180868 |