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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

Must not have

History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted

Prior radiotherapy to the abdomen or pelvis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

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

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I have never had lung conditions like pulmonary fibrosis or pneumonitis, except for fibrosis from radiation.

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I have had radiation therapy to my abdomen or pelvis before.

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I am currently using hormone replacement therapy or oral contraceptives.

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I have a serious wound, ulcer, or untreated bone fracture that is not healing.

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I haven't had cancer treatments like chemotherapy in the last 3 weeks.

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I have not taken hormonal therapy for my condition in the last week.

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I have not been treated with specific immune therapies before.

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I haven't taken any immune-boosting drugs like interferon or interleukin in the last 6 weeks.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I do not have active tuberculosis.

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I have diabetes (type 1 or 2) that is well-managed with medication.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I need help with getting hydrated or fed through tubes.

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I need to continue using a specific bone-strengthening medication during my cancer treatment.

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I have a significant liver condition, such as hepatitis or cirrhosis.

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I have or am at risk for an autoimmune disease.

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I have not had severe infections or been hospitalized for them in the last 4 weeks.

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I haven't had a live vaccine in the last 4 weeks and won't need one during the study.

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I need a tube to drain my stomach.

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I do not have serious heart or brain blood vessel problems.

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I have unstable chest pain.

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My heart condition limits my physical activity.

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I haven't had any major issues with my abdomen or throat leading to holes or severe infections in the last 6 months.

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I have previously been treated with PLD.

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I have not had signs of infection in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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 dose limiting toxicities (DLT) of experimental regimens

Overall survival (OS) (Phase III)

PFS (Phase III)

+1 more

Secondary study objectives

Disease-related symptoms (Phase II)

Disease-related symptoms (Phase III)

Frequency and severity of adverse events (Phase II)

+6 more

Other study objectives

Changes in quantitative biomarker parameters in tissue, blood, and stool

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

posterior capsule opacification

vitreous syneresis

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

No Placebo-Only Group

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

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

~5540

Computed Tomography

2017

Completed Phase 2

~2740