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Monoclonal Antibodies
Chemotherapy + Immunotherapy for Recurrent Ovarian Cancer
Phase 2 & 3
Waitlist Available
Led By Roisin E O'Cearbhaill
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease (defined by RECIST v1.1) or evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease related in the setting of cancer antigen [CA] 125 >= 2 x upper limit of normal [ULN])
Performance status 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back.
Who is the study for?
This trial is for adults with recurrent ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based therapy. Participants must have good general health and psychological ability to complete the study, no more than two prior cancer treatments (excluding certain hormonal therapies), and agree to use contraception due to risks posed by the treatment on pregnancy.Check my eligibility
What is being tested?
The trial is testing how well a chemotherapy drug called pegylated liposomal doxorubicin hydrochloride works when combined with atezolizumab and/or bevacizumab. These drugs may help stop tumor growth by killing cells or preventing them from dividing or spreading. The effectiveness of different combinations will be compared in patients.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, increased risk of infection due to immune system suppression, potential harm to an unborn baby if pregnant while receiving treatment, allergic reactions related to monoclonal antibodies used in this study (atezolizumab and bevacizumab), as well as other organ-specific inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured by scans or has signs that doctors can evaluate.
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I can take care of myself but might not be able to do heavy physical work.
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My blood clotting tests are normal or I'm on a stable blood thinner dose.
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I am 18 years old or older.
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I agree to use birth control during and 5 months after the study due to risks to pregnancy.
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I have a specific type of advanced ovarian cancer and can provide a pathology report.
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My ovarian cancer came back and didn't respond to platinum therapy within 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities (DLT) of experimental regimens
Overall survival (OS) (Phase III)
PFS (Phase III)
+1 moreSecondary outcome measures
Disease-related symptoms (Phase II)
Disease-related symptoms (Phase III)
Frequency and severity of adverse events (Phase II)
+6 moreOther outcome measures
Changes in quantitative biomarker parameters in tissue, blood, and stool
Side effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (PLD, bevacizumab, atezolizumab)Experimental Treatment5 Interventions
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15. Patients also undergo CT on study.
Group II: Arm I (PLD, atezolizumab)Experimental Treatment4 Interventions
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021)
Group III: Arm III (PLD, bevacizumab)Active Control4 Interventions
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also undergo CT on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Computed Tomography
2017
Completed Phase 2
~2720
Pegylated Liposomal Doxorubicin Hydrochloride
2001
Completed Phase 3
~4520
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,710 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
100,409 Total Patients Enrolled
Roisin E O'CearbhaillPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping ability is less than or equal to 50%, as shown by a special heart test.I have not had a stroke or mini-stroke in the last 6 months.I have stable autoimmune hypothyroidism and am on a consistent thyroid hormone dose.I have had 1-2 treatments for my condition, not counting hormonal or certain maintenance therapies.You have had a bone marrow or solid organ transplant in the past.I have never had lung conditions like pulmonary fibrosis or pneumonitis, except for fibrosis from radiation.Your bilirubin level should be within a certain range, but if you have a condition called Gilbert disease, a slightly higher level may be allowed.I have had radiation therapy to my abdomen or pelvis before.Your thyroid-stimulating hormone (TSH) levels should be normal, unless you are on thyroid replacement therapy, in which case your TSH should be below a certain level.I am currently using hormone replacement therapy or oral contraceptives.My cancer can be measured by scans or has signs that doctors can evaluate.I can take care of myself but might not be able to do heavy physical work.I am using inhaled corticosteroids or fludrocortisone for low blood pressure or adrenal gland issues.You have had strong allergic reactions to certain types of medications made from proteins.You have a condition that causes frequent or significant bleeding, or problems with blood clotting.I have a serious wound, ulcer, or untreated bone fracture that is not healing.I have coughed up a noticeable amount of blood recently.Your blood pressure is too high and not well controlled.I am mentally and physically able to follow the study's requirements.Your white blood cell count is at least 1,500 per microliter.Your platelet count is at least 100,000 per microliter within the last 14 days before joining the study.Your hemoglobin level needs to be at least 8 grams per deciliter within 14 days before joining the study.Your kidney function, as measured by creatinine levels, must be within a certain range.Your liver enzyme levels are not more than 3 times the upper limit of normal, or not more than 5 times the upper limit of normal if you have liver involvement. This will be checked within 14 days before you join the study.I haven't had cancer treatments like chemotherapy in the last 3 weeks.I have not taken hormonal therapy for my condition in the last week.I have not been treated with specific immune therapies before.I haven't taken any immune-weakening medications in the last 2 weeks.I do not have active tuberculosis.I have not taken antibiotics in the last 2 weeks, except for prevention.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I have been cancer-free for at least 3 years, except for non-dangerous skin cancer or very early-stage breast or cervical cancer.I have had signs or symptoms of a blocked intestine in the last 28 days.I need help with getting hydrated or fed through tubes.I need to continue using a specific bone-strengthening medication during my cancer treatment.I have a significant liver condition, such as hepatitis or cirrhosis.I had hepatitis B in the past but it's resolved now.I have hepatitis C antibodies but no active virus according to a PCR test.I am 18 years old or older.I have not had severe infections or been hospitalized for them in the last 4 weeks.I haven't had a live vaccine in the last 4 weeks and won't need one during the study.I haven't had major blood vessel problems like aneurysms or clots needing surgery in the last 6 months.My ovarian cancer came back and didn't respond to platinum therapy within 6 months.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My kidney function test for protein in urine is normal.I had radiation for bone cancer spread more than 2 weeks ago.I have skin conditions like eczema or psoriasis without severe symptoms.I have diabetes (type 1 or 2) that is well-managed with medication.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I need a tube to drain my stomach.I have had bevacizumab or similar treatments for cancer that came back despite platinum-based therapy.I have not received a live flu vaccine within the last 4 weeks.I do not have serious heart or brain blood vessel problems.My blood clotting tests are normal or I'm on a stable blood thinner dose.I do not have brain cancer or symptoms from cancer spread to my brain.I have unstable chest pain.I have recovered from side effects of previous treatments, except for hair loss.I stopped any cancer-related herbal treatments at least a week ago.I haven't taken any immune-boosting drugs like interferon or interleukin in the last 6 weeks.My heart condition limits my physical activity.I have a specific type of advanced ovarian cancer and can provide a pathology report.I have only taken low dose immunosuppressants briefly, for example, for nausea.I have used bisphosphonates for reasons other than high calcium levels in the last 28 days.I have brain metastases from cancer but don't have symptoms because they've been treated.I have or am at risk for an autoimmune disease.I have brain involvement from my cancer but no symptoms, and meet specific health criteria.I had a heart attack in the last 6 months.I haven't had any major issues with my abdomen or throat leading to holes or severe infections in the last 6 months.I agree to use birth control during and 5 months after the study due to risks to pregnancy.I can provide a sample of my tumor for the trial.I have previously been treated with PLD.I have not had signs of infection in the last 2 weeks.You are allergic to Chinese hamster ovary cell products or other man-made antibodies.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (PLD, atezolizumab)
- Group 2: Arm II (PLD, bevacizumab, atezolizumab)
- Group 3: Arm III (PLD, bevacizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Ovarian Cancer Patient Testimony for trial: Trial Name: NCT02839707 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients currently enrolled in this trial?
"Currently, this clinical trial is not enrolling patients. The study was initially posted on May 12th, 2017 and most recently updated on September 23rd, 2022. There are 4450 other trials for patients with ovary cancer that are currently recruiting participants and 1019 trials involving Bevacizumab."
Answered by AI
Are there any other similar medical studies that have used Bevacizumab?
"Bevacizumab was first trialed in 1997 at Spectrum Health Hospital - Butterworth Campus. Since then, there have been 1876 completed follow-up trials. As of now, 1019 studies are still ongoing; a large concentration of these are based out of Colorado Springs, Colorado."
Answered by AI
Has this type of research been undertaken before?
"Alfacell completed the first clinical study on bevacizumab in 1997, which then allowed the drug to progress to phase 3 trials. Currently, there are 1019 active studies being conducted in 2789 cities across 83 countries."
Answered by AI
Is this trial taking place at several locations across North America?
"This trial is available at 100 sites. You can check if there is a site near you by visiting the study's website. The locations are based in Colorado Springs, Santa Rosa and Henderson as well as other cities 100 other locations."
Answered by AI
What is the purpose of this research?
"The primary outcome of this trial is to Incidence of dose limiting toxicities (DLT) of experimental regimens. Secondary outcomes include Disease-related symptoms (Phase II) which is defined as Will be assessed by the National Comprehensive Cancer Network (NCCN)- Functional Assessment of Cancer Therapy (FACT) ovarian symptom index (NFOSI)-18 disease-related symptoms (DRS). A repeated measures model will be used to estimate and compare the mean DRS-P scores for the treatment groups. Model covariates will include the patients' randomly assigned study treatment, age at enrollment onto the study, initial performance status,"
Answered by AI
What are the most common Bevacizumab treatments?
"Bevacizumab is used to treat advanced soft tissue sarcoma, as well as other conditions like skin infections from staphylococcus aureus or escherichia coli, and yaws."
Answered by AI
How many total participants are needed for this research project?
"This study is no longer recruiting patients. However, when it was active, the trial was posted on 5/12/2017 and last updated on 9/23/2022. If you are interested in other clinical studies, there are currently 4450 trials actively enrolling patients with ovary cancer and 1019 trials for Bevacizumab actively recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
Thompson Oncology Group-Oak Ridge
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I've had chemo (6) treatments to cure my ovarian cancer. It did not work!
PatientReceived no prior treatments
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