What side effects are associated with this type of intervention?

The most common treatments for Fallopian Tube Carcinoma, similar to those in the APL-2 trial, include APL-2, pembrolizumab, and bevacizumab. Pembrolizumab can cause fatigue, rash, gastrointestinal issues, and immune-related adverse effects such as pneumonitis and colitis. Bevacizumab is associated with hypertension, proteinuria, and increased risks of bleeding and thromboembolic events. Combining these treatments may lead to overlapping toxicities, requiring careful monitoring.

What prior FDA approvals exist?

FDA-approved treatments for Fallopian Tube Carcinoma that align with the mechanisms of APL-2 include bevacizumab and pembrolizumab. Bevacizumab, a monoclonal antibody, inhibits angiogenesis, thereby limiting tumor growth and malignant effusion. Pembrolizumab, an immune checkpoint inhibitor, enhances the immune system's ability to target and destroy cancer cells. These treatments have been approved for use in various combinations for recurrent ovarian, fallopian tube, and primary peritoneal cancers, reflecting their roles in limiting tumor progression and improving immune response.

What other types of research exist?

Promising alternatives to APL-2 for Fallopian Tube Carcinoma patients include: 1) Pembrolizumab, an immunotherapy that helps the immune system attack cancer cells and may interfere with tumor growth and spread. 2) Bevacizumab, a monoclonal antibody that inhibits tumor growth and spread. 3) Combination therapies such as pembrolizumab with bevacizumab, which may offer enhanced efficacy in treating recurrent ovarian, fallopian tube, or primary peritoneal cancer with malignant effusion.

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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

Bevacizumab

2013

Completed Phase 4

~5280

Biospecimen Collection

2004

Completed Phase 2

~1720

Biopsy

2014

Completed Phase 4

~1090

Pembrolizumab

2017

Completed Phase 2

~2010

Pegcetacoplan

2015

Completed Phase 3

~380

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Fallopian Tube Carcinoma include APL-2, pembrolizumab, and bevacizumab. APL-2 works by limiting tumor progression, decreasing malignant effusion, and enhancing the immune response. Pembrolizumab, an immunotherapy, blocks the PD-1 pathway to help the immune system attack cancer cells. Bevacizumab inhibits angiogenesis, preventing tumors from developing new blood vessels. These treatments are significant for patients as they target various mechanisms of tumor growth and spread, potentially improving treatment efficacy and patient outcomes.

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