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C3 Complement Inhibitor

APL-2 + Pembrolizumab +/- Bevacizumab for Ovarian Cancer

Phase 2
Recruiting
Led By Emese Zsiros
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recurrent epithelial ovarian/fallopian tube or primary peritoneal cancer based on imaging or synchronous primary ovarian and uterine cancer patients with specified histology subtypes
Age >= 18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is studying the safety and effect of C3 complement inhibitor APL-2 (Pegcetacoplan) alone and in combination with Pembrolizumab, as well as APL-2 in combination with both Bevacizumab and Pembrolizumab in patients with recurrent ovarian, fallopian tube or primary peritoneal cancer with symptomatic malignant effusion (ascites or pleural effusion).

Who is the study for?
This trial is for adults over 18 with recurrent ovarian, fallopian tube, or primary peritoneal cancer who haven't had Bevacizumab or immune checkpoint inhibitors in the last 9 weeks. They should have a life expectancy of at least 3 months and be able to self-administer APL-2 (Pegcetacoplan). Pregnant women and those on recent cancer therapy or immunosuppressants can't participate.Check my eligibility
What is being tested?
The study tests APL-2 (Pegcetacoplan) alone, combined with Pembrolizumab, and alongside both Bevacizumab and Pembrolizumab against Bevacizumab alone. It aims to improve immune response and reduce fluid buildup in patients with symptomatic malignant effusion due to certain cancers.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's increased activity, such as inflammation in various organs. There may also be risks associated with injections like infusion reactions. Specific side effects will depend on the combination of drugs received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned in the ovary, fallopian tube, or peritoneum, or I have both ovarian and uterine cancer.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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I can take my medication by myself.
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I haven't taken bevacizumab, pembrolizumab, or similar drugs in the last 9 weeks.
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I have had fluid drained from my abdomen or chest, or have a drainage tube, within the last 4 weeks.
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I am willing to get vaccinations if needed for the trial.
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I have no known allergies or adverse reactions to bevacizumab or pembrolizumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accumulation of effusion (Phase 2b)
Secondary outcome measures
Best response
Disease control rate
Overall response rate
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2B-3 (bevacizumab)Experimental Treatment3 Interventions
Group II: Cohort 2B-2 (pegcetacoplan, pembrolizumab, bevacizumab)Experimental Treatment5 Interventions
Group III: Cohort 2B-1 (pegcetacoplan, pembrolizumab)Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Pembrolizumab
2017
Completed Phase 2
~2010
Pegcetacoplan
2015
Completed Phase 3
~380

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
399 Previous Clinical Trials
30,728 Total Patients Enrolled
4 Trials studying Ovarian Cancer
63 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,595 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,708 Patients Enrolled for Ovarian Cancer
Emese ZsirosPrincipal InvestigatorRoswell Park Cancer Institute
4 Previous Clinical Trials
169 Total Patients Enrolled

Media Library

Pegcetacoplan (C3 Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04919629 — Phase 2
Ovarian Cancer Research Study Groups: Cohort 2B-2 (pegcetacoplan, pembrolizumab, bevacizumab), Cohort 2B-3 (bevacizumab), Cohort 2B-1 (pegcetacoplan, pembrolizumab)
Ovarian Cancer Clinical Trial 2023: Pegcetacoplan Highlights & Side Effects. Trial Name: NCT04919629 — Phase 2
Pegcetacoplan (C3 Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04919629 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any safety risks associated with using Pembrolizumab?

"The safety of Pembrolizumab was assessed at a score of 2, as this is Phase 2 trial with supporting data on the drug's security but no information yet regarding its effectiveness."

Answered by AI

Has Pembrolizumab been evaluated in any other scientific experiments?

"Currently, there are over 1300 investigations into the effects of Pembrolizumab with 212 in Phase 3. Out of a total 52409 sites studying this medication worldwide, several can be found in Pittsburgh, Pennsylvania."

Answered by AI

To what maladies is Pembrolizumab typically employed?

"Pembrolizumab is an approved treatment option for those with unresectable melanoma and other conditions such as microsatellite instability high, locally advanced nonsquamous non-small cell lung cancer, or a heightened chance of recurrence."

Answered by AI

Does this research still have openings for participants?

"According to the details provided on clinicaltrials.gov, this trial is no longer in its recruitment phase; it was first posted on December 15th 2022 and last updated October 31st 2022. However, there are currently 5,224 other trials actively seeking patients."

Answered by AI

How many participants have subscribed to this clinical research?

"Recruitment for this particular medical trial has ended, as the last edit was recorded on October 31st 2022. Currently, 3922 trials are actively trying to recruit patients with primary peritoneal adenocarcinoma and another 1302 studies require participants for Pembrolizumab."

Answered by AI
~27 spots leftby Apr 2026