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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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)

Incidence of adverse events (Phase 2a)

Secondary outcome measures

Best response

Disease control rate

Overall response rate

+3 more

Other outcome measures

APL-2 pharmacokinetics (PK)/pharmacodynamics (PD) and immunological

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 2B-3 (bevacizumab)Experimental Treatment4 Interventions

Patients receive bevacizumab IV on day 1 of each cycle. Treatment repeats every 3 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy and blood sample collection throughout the study.

Group II: Cohort 2B-2 (pegcetacoplan, pembrolizumab, bevacizumab)Experimental Treatment6 Interventions

Patients receive pegcetacoplan IV over 20-40 minutes on day 1 of cycle 1 and then SC BIW of each cycle. Patients also receive pembrolizumab IV and bevacizumab IV on day 1 of each cycle. Treatment repeats every 3 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive pembrolizumab for up to 35 21-day cycles in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy and blood sample collection throughout the study.

Group III: Cohort 2B-1 (pegcetacoplan, pembrolizumab)Experimental Treatment5 Interventions

(Expansion) Patients receive pegcetacoplan IV over 20-40 minutes on day 1 of cycle 1 and then SC BIW of each cycle. Treatment repeats every 3 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles, followed by every 42 days for up to 35 total cycles in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy and blood sample collection throughout the study.

Group IV: Cohort 2A-2 (pegcetacoplan, pembrolizumab, bevacizumab)Experimental Treatment6 Interventions

Patients receive pegcetacoplan IV over 20-40 minutes on day 1 of cycle 1 and then SC BIW of each cycle. Patients also receive pembrolizumab IV and bevacizumab IV on day 1of each cycle. Treatment repeats every 3 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive pembrolizumab for up to 35 21-day cycles in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy and blood sample collection throughout the study.

Group V: Cohort 2A-1 (pegcetacoplan, pembrolizumab)Experimental Treatment5 Interventions

Patients receive pegcetacoplan IV over 20-40 minutes on day 1 of cycle 1 and then SC BIW of each cycle. Patients also receive pembrolizumab IV on day 1 of each cycle. Treatment repeats every 3 weeks for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive pembrolizumab for up to 35 21-day cycles in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700

Bevacizumab

2013

Completed Phase 4

~5280

Pembrolizumab

2017

Completed Phase 2

~2010

Pegcetacoplan

2015

Completed Phase 3

~380

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

31,067 Total Patients Enrolled

2 Trials studying Fallopian Tube Carcinoma

59 Patients Enrolled for Fallopian Tube Carcinoma

National Cancer Institute (NCI)NIH

13,692 Previous Clinical Trials

40,929,915 Total Patients Enrolled

23 Trials studying Fallopian Tube Carcinoma

6,798 Patients Enrolled for Fallopian Tube Carcinoma

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

Fallopian Tube Carcinoma Research Study Groups: Cohort 2A-1 (pegcetacoplan, pembrolizumab), Cohort 2A-2 (pegcetacoplan, pembrolizumab, bevacizumab), Cohort 2B-2 (pegcetacoplan, pembrolizumab, bevacizumab), Cohort 2B-3 (bevacizumab), Cohort 2B-1 (pegcetacoplan, pembrolizumab)

Fallopian Tube Carcinoma 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

Recent research and studies

clinicaltrials.govStudy

APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion

2023. "APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04919629.

All > Peritoneal Cancer > Recurrent Ovarian Cancer