Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am post-menopausal or not currently pregnant.
Select...
My cancer got worse or came back within 6 months after platinum-based treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have no standard treatment options left for my condition.
Select...
My cancer is a recurrent high-grade type in the ovary, peritoneum, or fallopian tube.
Select...
My body weight is over 30 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
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
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,769 Total Patients Enrolled
4 Trials studying Fallopian Tube Carcinoma
600 Patients Enrolled for Fallopian Tube Carcinoma
Aravive Biologics IncUNKNOWN
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,774 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had an autoimmune or inflammatory disorder.You have a disease that can be measured using specific guidelines.I have moderate to severe nerve damage.I don't have lasting side effects from cancer treatment worse than grade 2.I am post-menopausal or not currently pregnant.Your heart's electrical activity, called the QT interval, is longer than 470 milliseconds when adjusted for your heart rate.I do not have any unmanaged ongoing illnesses.I have cancer that has spread to my brain or spinal cord.My cancer got worse or came back within 6 months after platinum-based treatment.You have a high number of a type of white blood cell called neutrophils.I have an ongoing blockage in my intestines.I received my last cancer treatment less than 28 days ago.I am not currently on any cancer treatments like chemotherapy or hormone therapy.Your bilirubin level in the blood is not higher than 1.5 times the normal limit.I have not taken immunosuppressive drugs in the last 14 days.I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.Your platelet count is at least 100 billion per liter.I have had another type of cancer.I have not received a live vaccine in the last 30 days.I am willing and able to follow the study's requirements, including treatments and visits.I have side effects from past treatments that won't get worse with durvalumab.I am not pregnant or breastfeeding and agree to use birth control during and up to 180 days after treatment.I am fully active or restricted in physically strenuous activity but can do light work.You are expected to live for at least 12 more weeks.Your hemoglobin level is 9.0 grams per deciliter or higher.I have not had major surgery in the last 28 days.I have no standard treatment options left for my condition.You have received an organ transplant from another person.My cancer is a recurrent high-grade type in the ovary, peritoneum, or fallopian tube.My body weight is over 30 kg.My liver function tests are within normal limits, or slightly above if I have liver metastases.Your kidneys are working well and can filter out waste products.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (batiraxcept, durvalumab)
- Group 2: Arm II (durvalumab, batiraxcept)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have consented to this clinical trial?
"At present, this medical trial is not presently enrolling patients. The clinical trial was first listed on October 11th 2019 and the latest update occurred on December 8th 2022. There are currently 3693 studies recruiting for recurrent ovarian carcinoma, as well as 334 trials actively seeking participants to test out Batiraxcept."
Answered by AI
Have there been prior investigations utilizing Batiraxcept?
"Currently, there are 334 active clinical trials with 51 of those in the final Phase 3 stage. Although most studies for Batiraxcept originate from Nashville, Tennessee, this drug is being explored at 12994 different sites worldwide."
Answered by AI
How has Batiraxcept been implemented as a treatment option?
"Batiraxcept is a common treatment for stage 3 unresectable non-small cell lung cancer. Additionally, it has been employed to treat metastatic ureteral carcinoma and advanced directives."
Answered by AI
Are there any openings to participate in this experiment?
"Clinicaltrials.gov attests that the posted trial, which was established in October 2019 and updated last December, is not accepting applicants presently. However, there are still plenty of other medical trials available with 4027 being open for recruitment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger