What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as pegylated liposomal doxorubicin (PLD), bevacizumab, and PARP inhibitors (e.g., olaparib, niraparib, rucaparib), have several known side effects. PLD is associated with myelotoxicity, including neutropenia and thrombocytopenia, as well as hand-foot syndrome and stomatitis. Bevacizumab can cause hypertension, proteinuria, and an increased risk of gastrointestinal perforation. PARP inhibitors often lead to nausea, fatigue, vomiting, and anemia. These side effects are important considerations when evaluating the safety and efficacy of combination treatments like Maplirpacept (PF-07901801) with PLD.

What prior FDA approvals exist?

The FDA has approved pegylated liposomal doxorubicin (PLD) as a standard treatment for platinum-resistant ovarian cancer, with response rates between 12 to 35%. Additionally, the combination of PLD with bevacizumab, an anti-angiogenic monoclonal antibody, has been approved to enhance the efficacy of PLD in treating this condition. These treatments aim to provide more effective therapeutic options for patients with platinum-resistant ovarian cancer.

What other types of research exist?

Promising alternatives to Maplirpacept (PF-07901801) combined with PLD for treating platinum-resistant ovarian cancer include: 1) PARP inhibitors such as Olaparib, which have shown significant improvement in progression-free survival (PFS) in patients with BRCA mutations. 2) Bevacizumab combined with chemotherapy, which is FDA-approved and has demonstrated efficacy in this patient group. 3) Pembrolizumab combined with chemotherapy, which has shown improved PFS and overall survival (OS) in clinical trials for recurrent or metastatic ovarian cancer.

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Chemotherapy

Maplirpacept + PLD for Ovarian Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Trillium Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Platinum-resistant disease (progression ≥1 month and ≤6 months after a minimum of four cycles of last platinum-based treatment)

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Must not have

Non-epithelial histology, including malignant mixed Mullerian tumors

Ovarian tumors with low malignant potential (i.e., borderline tumors), low grade serous ovarian cancer or carcinosarcoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy whichever occurred first (up to approximately 33 weeks; maximum exposure of study treatment = 32 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, maplirpacept, combined with an existing chemotherapy drug, PLD, for patients with ovarian cancer that doesn't respond to standard treatments. The goal is to see if this combination is safe and more effective. Patients will be monitored regularly to check for improvements and any side effects.

Who is the study for?

This trial is for women with platinum-resistant ovarian cancer, including cancers of the ovary, fallopian tube, or peritoneum. Participants should have measurable disease and be in good physical condition (ECOG 0-1), with proper organ function. They must have progressed after standard treatments or cannot tolerate them. Women who've had more than four prior treatments for their resistant disease or those with certain heart conditions, CNS metastases, severe bleeding disorders, hypersensitivity to antibodies, or autoimmune diseases requiring intense treatment are excluded.

What is being tested?

The study tests maplirpacept combined with Pegylated Liposomal Doxorubicin (PLD) chemotherapy in patients who haven't responded well to platinum-based therapies. Initially, it will determine the safest dose of maplirpacept to use alongside PLD by gradually increasing doses. Once a safe combination is found, more participants will receive this regimen over 28-day cycles until they experience significant side effects or their disease worsens.

What are the potential side effects?

Potential side effects include reactions related to the immune system due to maplirpacept such as inflammation in various organs and infusion-related reactions; from PLD there may be fatigue, digestive issues like nausea and mouth sores; skin problems like hand-foot syndrome; low blood counts leading to increased infection risk; and potential heart toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer got worse 1 to 6 months after my last platinum-based treatment.

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I am fully active or can carry out light work.

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I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

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My side effects from previous treatments are mild, except for hair loss or stable nerve pain.

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I have had 4 or fewer treatments for my platinum-resistant condition.

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My cancer is confirmed to be ovarian, fallopian tube, or peritoneal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is not of the common 'epithelial' type; it could be a mixed Mullerian tumor.

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My ovarian tumor is low-grade or borderline.

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I have had a heart attack or other heart-related emergency.

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I have a history of serious heart failure.

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I am currently on systemic steroid therapy.

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I have an autoimmune disease treated with specific drugs.

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I have had an organ or stem cell transplant.

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I have a history of significant bleeding disorders or episodes.

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I have previously been treated with anti-CD47 or anti-SIRPα therapy.

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I have had brain metastases or carcinomatous meningitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy whichever occurred first (up to approximately 33 weeks; maximum exposure of study treatment = 32 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy whichever occurred first (up to approximately 33 weeks; maximum exposure of study treatment = 32 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment up to 30 days (+5) after last dose of study treatment or 1 day before starting day of new anti-cancer drug therapy whichever occurred first (up to approximately 33 weeks; maximum exposure of study treatment = 32 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Secondary study objectives

Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

Phase 1: Change From Baseline in Diastolic and Systolic Blood Pressure (BP) at End of Treatment

Phase 1: Change From Baseline in Pulse Rate at End of Treatment

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: Dose ExpansionExperimental Treatment2 Interventions

In the Phase 2 (dose expansion): maplirpacept (PF-07901801) will be administered with selected dose from the escalation phase by intravenous infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 in subsequent cycles in combination with Pegylated Liposomal Doxorubicin 40 mg/m2 by intravenous infusion on Day 1 of each 28-day cycle.

Group II: Phase 1: Dose EscalationExperimental Treatment2 Interventions

In the Phase 1 (dose escalation): Cycle 1 for dose levels 1 and 2, maplirpacept (PF-07901801) will be administered on Day 1, Day 8, Day 15 and Day 22 in combination with PLD on Day 1 of 28-day cycle. Beginning with Cycle 2 at dose levels 1 and 2, maplirpacept (PF-07901801) will be administered on Day 1 and Day 15 in combination with PLD on Day 1 of 28-day cycles. For Phase 1, dose level 3, maplirpacept (PF-07901801) will be administered on Day 1 and Day 15 in combination with PLD on Day 1 of 28-day cycles. Dose level 3 will be biweekly regimen from the start.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

maplirpacept (PF-07901801)

2022

Completed Phase 1

~10

Pegylated Liposomal Doxorubicin (PLD)

2016

Completed Phase 2

~90

0 / 16Eligibility 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

Pegylated Liposomal Doxorubicin (PLD) works by intercalating DNA, disrupting replication and transcription, which leads to cell death. Its liposomal formulation allows for better targeting of cancer cells and reduced toxicity. PARP inhibitors, such as Olaparib, inhibit the PARP enzyme involved in DNA repair, causing cancer cells with BRCA mutations to accumulate DNA damage and die. Bevacizumab, an anti-angiogenesis agent, inhibits vascular endothelial growth factor (VEGF), reducing blood supply to tumors and inhibiting their growth. These mechanisms are crucial for ovarian cancer patients as they target cancer cells more effectively, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

Clinical Benefits of Olaparib in Mexican Ovarian Cancer Patients With Founder Mutation BRCA1-Del ex9-12.Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial.