Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05231122
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2022-01-24
Brief Title:
Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Randomized Phase 2 Clinical Trial of Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 in Patients With Recurrent Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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 whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back recurrent Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and when combined with other immunotherapy treatments may increase antitumor antibody production Immunotherapy with monoclonal antibodies such as pembrolizumab and bevacizumab may help the bodys immune system and may interfere with the ability of tumor cells to grow and spread Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms prolonged survival and improve quality of life in patients with ovarian cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety of anti-CD40 agonist monoclonal antibody CDX-1140 CDX-1140 combined with pembrolizumab and bevacizumab in patients with recurrent ovarian cancer Common Terminology Criteria for Adverse Events CTCAE version 50
II Determine the objective response rate ORR per immune related response criteria immune-modified Response Evaluation Criteria in Solid Tumors iRECIST
SECONDARY OBJECTIVES
I Determine progression free survival PFS disease control rate DCR and overall survival OS
II Changes in quality of life measures during the clinical trial European Organization for Research and Treatment of Cancer EORTC Quality of Life Questionnaire-Core 30 QLQ-C30 EORTC QLQ-Ovarian Cancer Module OV28 and Multidimensional Fatigue Symptom Inventory-Short Form MFSI-SF
EXPLORATORY OBJECTIVES
I Pharmacokinetic PKanti-drug antibody ADA analysis for CDX-1140 II Evaluate the immunologic and phenotypic changes in blood samples III To obtain data on changes in tumor microenvironment prior to and subsequent to therapy and to screen for potential biomarkers to predict clinical benefit
IV Microbiome analysis from stool tumor tissue
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive pembrolizumab intravenously IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity
ARM II Patients receive pembrolizumab IV over 30 minutes bevacizumab IV over 30-90 minutes and CDX-1140 IV over 90 minutes on day 1 Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 6 months for 2 years
I Determine the safety of anti-CD40 agonist monoclonal antibody CDX-1140 CDX-1140 combined with pembrolizumab and bevacizumab in patients with recurrent ovarian cancer Common Terminology Criteria for Adverse Events CTCAE version 50
II Determine the objective response rate ORR per immune related response criteria immune-modified Response Evaluation Criteria in Solid Tumors iRECIST
SECONDARY OBJECTIVES
I Determine progression free survival PFS disease control rate DCR and overall survival OS
II Changes in quality of life measures during the clinical trial European Organization for Research and Treatment of Cancer EORTC Quality of Life Questionnaire-Core 30 QLQ-C30 EORTC QLQ-Ovarian Cancer Module OV28 and Multidimensional Fatigue Symptom Inventory-Short Form MFSI-SF
EXPLORATORY OBJECTIVES
I Pharmacokinetic PKanti-drug antibody ADA analysis for CDX-1140 II Evaluate the immunologic and phenotypic changes in blood samples III To obtain data on changes in tumor microenvironment prior to and subsequent to therapy and to screen for potential biomarkers to predict clinical benefit
IV Microbiome analysis from stool tumor tissue
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive pembrolizumab intravenously IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity
ARM II Patients receive pembrolizumab IV over 30 minutes bevacizumab IV over 30-90 minutes and CDX-1140 IV over 90 minutes on day 1 Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 6 months for 2 years
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-13609 | REGISTRY | None | None |
| I 1277721 | OTHER | None | None |
| P30CA016056 | NIH | Roswell Park Cancer Institute | httpsreporternihgovquickSearchP30CA016056 |