Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03734692|
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : December 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Recurrent||Drug: Rintatolimod Drug: Pembrolizumab Drug: Cisplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer|
|Actual Study Start Date :||January 28, 2019|
|Estimated Primary Completion Date :||February 20, 2021|
|Estimated Study Completion Date :||November 20, 2023|
Experimental: cisplatin + rintatolimod + pembrolizumab
Intraperitoneal (IP) cisplatin 50mg/m^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution.
200 mg by IP administration over 1-2 hours
Other Name: Ampligen
200 mg will be administered as a 30 minute IV infusion
Other Name: Keytruda
Other Name: Platinol
- Objective Response Rate (ORR) [ Time Frame: At 13 weeks ]The proportion of subjects with the best response of complete response (CR), or partial response (PR) per Response Evaluation Criteria for Solid Tumors (RECIST 1.1). Per RECIST 1.1 , CR is defined as all target lesions gone; PR is defined as a > 30% decrease in size of lesion from baseline.
- Progression-Free Survival (PFS) [ Time Frame: up to 4 years ]The length of time during and after study treatment that a patient remains alive without worsening disease. Per RECIST 1.1, progression is defined as a > 20% increase from smallest sum of longest (lesion) diameter recorded since treatment started (best response - target lesions) and/or, enlargement of non-target lesions.
- Change in number of CD8+ cells [ Time Frame: At baseline (pre-treatment) and at 8 weeks (after the start of treatment) ]Within-patient changes in number of CD8+ cells present in tumor tissue and peritoneal fluid.
- Change in number of CD3+ cells [ Time Frame: at baseline (pre-treatment) and at 12 weeks (after the start of treatment) ]Within-patient changes in number of CD3+ cells present in tumor tissue and peritoneal fluid.
- NK Cells [ Time Frame: at baseline (pre-treatment) and at 12 weeks (after the start of treatment) ]
- Grandzyme B [ Time Frame: at baseline (pre-treatment) and at 12 weeks (after the start of treatment) ]
- CD4 Tbet [ Time Frame: at baseline (pre-treatment) and at 12 weeks (after the start of treatment) ]
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): NCT03734692
|Contact: Robert Edwards, MDfirstname.lastname@example.org|
|Contact: Brenda Steele, RNemail@example.com|
|Principal Investigator:||Robert Edwards, MD||UPMC Hillman Cancer Center|