First-line Olaparib Combined With Bevacizumab Maintenance Therapy

June 29, 2022 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcomes of First-line Olaparib Combined With Bevacizumab Maintenance Therapy in Newly Diagnosed Ovarian Cancer Patients With tBRCA Wild-type Tumors: a Real-world Study

Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib plus bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION（ NMPA） -approved agent for ovarian cancer patients. In this setting, there is no olaparib plus bevacizumab maintenance therapy RWS data amongst 1st tBRCAwt patients in China, while this treatment regimen has been used in Chinese clinical practise by some doctors based on above-mentioned data.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective is to evaluate the outcome of olaparib plus bevacizumab combination maintenance therapy by proportion of patients alive and progression free at 1 year (1-yr PFSrate) We hypothesize that olaparib plus bevacizumab maintenance therapy could be beneficial for tBRCAwt high-grade serous ovarian cancer (HGSOC) patients who are treated with platinum-based first-line chemotherapy.

The secondary objectives are to evaluate the outcomes of olaparib plus bevacizumab maintenance therapy by: 1) 2-yr PFS rate; 2) median PFS; 3) median Time to First Subsequent Therapy or death (mTFST) ; 4) post-progression treatment after first progression; 5) reason for olaparib plus bevacizumab dose adjustment, dose interruptions, and dose discontinuations; 6) Reason for use of concomitant therapy.

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients diagnosed with HGSOC who started first-line olaparib plus bevacizumab maintenance therapy from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) will be identified from the electronic medical record system.

Description

Inclusion Criteria:

  • Female Patients must be ≥18 years old at diagnosis.
  • Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer and received olaparib and plus bevacizumab from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required)
  • Patients must have a tumor BRCA testing result which is tBRCAwt, defined as tumor BRCA wild type (patients without evidence of BRCA 1 and/or BRCA 2 deleterious or suspected deleterious mutations)
  • Patients who have completed first-line platinum-based chemotherapy and were in clinical complete response (CR) or in partial response (PR)
  • Patients who were still in CR or PR before receiving maintenance therapy
  • Patients who received at least one dose of olaparib plus bevacizumab maintenance therapy within three months after platinum-based chemotherapy and without disease progression

Exclusion Criteria:

  • Patient with multiple primary cancers as reported in EMR
  • Concomitant any anti- cancer therapy (chemotherapy, immunotherapy, hormonal therapy (Hormone replacement therapy (HRT) is acceptable), radiotherapy, biological therapy or other novel agent) during olaparib plus bevacizumab maintenance therapy.
  • Any previous treatment with PARP inhibitor.
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
  • Patients with symptomatic uncontrolled brain metastases.
  • Any other concerns related to decreased efficacy and safety of maintenance therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
olaparib plus bevacizumab treatment group
olaparib plus bevacizumab maintenance therapy in clinical practice and will be conducted in patients with tBRCAwt newly diagnosed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy following the standard of care from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) at tertiary-referral university hospitals and main cancer centers in China.
Drug: olaparib plus bevacizumab maintenance therapy
First-line olaparib plus bevacizumab maintenance therapy initiated from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-yr PFS rate
Time Frame: 12 months after date of first dose
the investigator assessed progression-free survival (PFS) at 1 year
12 months after date of first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-yr PFS rate
Time Frame: 24 months after date of first dose
the investigator assessed progression-free survival (PFS) at 2 year
24 months after date of first dose
Median PFS
Time Frame: Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
median progression-free survival
Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
mTFST
Time Frame: Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
median Time to First Subsequent Therapy or death
Median time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Post-progression treatment
Time Frame: Through study completion, an average of 1 year
The proportion of patients receiving each treatment after first progression through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-20-20889-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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