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Monoclonal Antibodies

Batiraxcept + Durvalumab for Ovarian Cancer

Phase 1 & 2

Waitlist Available

Led By Amir A Jazaeri

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients

Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment

Must not have

Active or prior documented autoimmune or inflammatory disorders

Patients with grade >= 2 neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of AVB-S6-500 in combination with durvalumab for patients with ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum therapy or has come back.

Who is the study for?

This trial is for patients with ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum therapy or has returned. Participants must have no standard treatment options left, measurable disease by certain criteria, good performance status and organ function. They can't join if they've had recent surgery, other treatments or clinical trials within the last month, uncontrolled illnesses, are pregnant/breastfeeding without birth control use, have known allergies to study drugs or severe unresolved toxicity from past cancer therapies.

What is being tested?

The trial is testing the combination of AVB-S6-500 with durvalumab to see what doses are safe and how these immunotherapies affect the immune system's ability to stop tumor growth in patients whose cancer didn't respond well to platinum-based chemotherapy.

What are the potential side effects?

Possible side effects include reactions related to stimulating the immune system which could lead to inflammation in various organs. There may also be infusion-related reactions alongside common symptoms like fatigue and digestive issues.

Eligibility Criteria

Inclusion Criteria

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

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I am post-menopausal or not currently pregnant.

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My cancer got worse or came back within 6 months after platinum-based treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have no standard treatment options left for my condition.

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My cancer is a recurrent high-grade type in the ovary, peritoneum, or fallopian tube.

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My body weight is over 30 kg.

Exclusion Criteria

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

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I have or had an autoimmune or inflammatory disorder.

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I have moderate to severe nerve damage.

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I don't have lasting side effects from cancer treatment worse than grade 2.

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I do not have any unmanaged ongoing illnesses.

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I have cancer that has spread to my brain or spinal cord.

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I have an ongoing blockage in my intestines.

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I am not currently on any cancer treatments like chemotherapy or hormone therapy.

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I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.

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I have had another type of cancer.

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I have not had major surgery in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

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: Arm II (durvalumab, batiraxcept)Experimental Treatment2 Interventions

Patients receive durvalumab IV over 60 minutes on days 1 and 22 of cycle 0 and on day 1 of subsequent cycles. Beginning cycle 1, patients also receive batiraxcept IV over 60 minutes on days 1 and 15. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (batiraxcept, durvalumab)Experimental Treatment2 Interventions

Patients receive batiraxcept IV over 60 minutes on days 1, 15, and 29 of cycle 0, and on days 1 and 15 of subsequent cycles. Beginning cycle 1, patients also receive durvalumab IV over 60 minutes on day 1. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Batiraxcept

2019

Completed Phase 2

~20

Durvalumab

2017

Completed Phase 2

~3750