Ovarian CancerPhase 2NCT06083844
Phase II Investigation of Pembrolizumab in Combination With Bevacizumab and Oral Cyclophosphamide in Patients With High Grade Ovarian Cancer and Surgically Documented Minimal Residual Disease After Frontline Therapy
A Phase 2 study testing Pembrolizumab, Bevacizumab and Cyclophosphamide in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
To find out if combining pembrolizumab, bevacizumab (or an equivalent biosimilar drug), and low-dose cyclophosphamide can help control high-grade ovarian cancer that has MRD after treatment. The safety of this treatment combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Pembrolizumab, Bevacizumab and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Dec 2023to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of high grade non-mucinous epithelial ovarian cancer will be enrolled in this study.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days after the last dose of study medication.
- The participant provides written informed consent for the trial.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
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- Have received standard of care frontline surgical and chemotherapy treatment (at least six cycles of platinum and taxane (or equivalent, with or without bevacizumab/biosimilar therapy). Patients who received neoadjuvant therapy are included. Omission of one or more doses of chemo for toxicity or hypersensitivity reaction is allowed. Have minimal residual disease (MRD) after a complete clinical response to frontline therapy (defined as: having a normalization of CA-125 and no obvious evidence of disease on exam or imaging unless the patient has an elevated CA-125 thought to be due to other confounding causes by the treating physician). Imaging with subtle or indeterminate findings will not disqualify participation.
- Having MRD is defined as either of the following conditions (must occur within 3 months on the last dose of frontline platinum-taxane chemotherapy):
- Second-look surgery that may be performed either as standard of care or in the context of a non-therapeutic clinical trial with positive tissue or cytology.
- OR
- Detectable ctDNA by the Signatera assay. Assay results that are "positive below analytical range" qualify as detectable.
- Participants who have undergone second look surgery, must have histologically confirmed residual ovarian cancer at time of second-look surgery. Patients with cytological evidence of malignant cells in washings obtained as part of the second look procedure are eligible even if biopsies are negative.
- Be willing to allow use of archival tissue from second-look surgery (if performed) and primary surgery or biopsy for use in this study.
- Have adequate organ function as determined by the following laboratory values:
- ANC ≥ 1,000 /mcL
- Platelets ≥ 100,000 / mcL
- Hgb ≥8 g/dL (transfusion allowed)
- Creatinine Clearance ≥30 mL/min (measured or calculated per local practice)
- Total Bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of suspected/documented Gilbert's Syndrome
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
- Have adequately recovered from second look surgery to be able to start the investigational regimen no sooner than 28 days from the date of second look surgery, and within 7 weeks of this procedure.
- Negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication (unless surgically sterile or postmenopausal for greater than one year).
Who cannot join
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Is currently receiving or has received an investigational agent within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Steroids to reduce risk of radiologic contrast allergy is permitted.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
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- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, type I diabetes mellitus, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Serious active infection that in the opinion of treating physician would preclude participation.
- Has a known history of uncontrolled Human Immunodeficiency Virus (HIV) infection. Patients with normal CD4 count and undetectable viral load will be eligible.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection that is active and has not been cured. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant.
- Clinically significant uncontrolled hypertension as defined by SBP>150 or DBP>90 persistently documented within 30 days of starting study directed treatment. Patients would be eligible if blood pressure controliscontrol is achieved with appropriate anti-hypertensive therapy. Rescreening after this therapy has been instituted is allowed.
- Histology showing mucinous or low-grade epithelial ovarian carcinoma.
- Documented deleterious germline or somatic BRCA mutations or tumors known to be homologous recombination deficiency (HRD) positive (e.g. as determined by MyChoice by Myriad Genetics (or other CLIA certified labs per PI's discretion).
- History of arterial thrombosis (pulmonary embolism in pulmonary arteries do not count as arterial thrombosis). Patients with history of DVT are eligible as long as they have received or are receiving appropriate anticoagulation therapy.
- History of gastrointestinal or urinary fistulae, non-healed or chronic wound, or other conditions that, in the investigator's view, would contraindicate or significantly increase the risks of bevacizumab/biosimilar therapy.
- Unable to understand or to comply with the study instructions and requirements or has a history of non-compliance to the medical regimen.
- Concurrent or planned use of any other anti-cancer systemic chemotherapy, biological therapy (including hormonal or immune therapy), radiation therapy, or live cancer vaccines.
- 24 Any other medical condition that in the investigator's judgement would significantly increase the risks of the investigational regimen.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Amir Jazaeri, MD, 713-745-1613, aajazaeri@mdanderson.org
Amir Jazaeri, MD
- Active, not recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
To find out if combining pembrolizumab, bevacizumab (or an equivalent biosimilar drug), and low-dose cyclophosphamide can help control high-grade ovarian cancer that has MRD after treatment. The safety of this treatment combination will also be studied.
Read the detailed description
Primary Objectives
- To determine whether the combination of pembrolizumab, bevacizumab (or equivalent biosimilars) and oral low dose cyclophosphamide can improve PFS by 6 months (compared to historical control/current trial) in patients with high grade ovarian cancer with residual disease identified by second look laparoscopy.
Secondary Objectives
- To determine the safety of the above regimen in this patient population.
Exploratory Objectives
- Correlating clinical benefit with gene expression and immune profiles of tumor tissue from SLL and confirmatory biopsy at the time of radiological progression.
- Tumor cell free tumor DNA (ctDNA) is emerging as a potentially sensitive marker of response in patients undergoing immunotherapy treatment(Lee et al. 2018). We will compare serial plasma ctDNA levels with response by RECIST v1.1.
- Conditions
- Ovarian Cancer
- Being tested
- Pembrolizumab, Bevacizumab, Cyclophosphamide
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called KEYTRUDA®
Given by IV (vein)
BevacizumabDrug
Also called Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Given by IV (vein)
CyclophosphamideDrug
Also called Cytoxan®, Neosar®
Given by mouth
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide | Experimental | Participants will begin receiving the study drug Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide.
Each study cycle is 21 days. Receives: Drug: Pembrolizumab; Drug: Bevacizumab; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start12 Dec 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Jazaeri, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083844
- Sponsor's protocol ID
- 2022-0685
- Other IDs
- NCI-2023-08686
- Status last verified
- May 2026
- First submitted
- 9 Oct 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Investigation of Pembrolizumab in Combination With Bevacizumab and Oral Cyclophosphamide in Patients With High Grade Ovarian Cancer and Surgically Documented Minimal Residual Disease After Frontline Therapy
- ClinicalTrials.gov ID
- NCT06083844
- Acronym / sponsor ID
- 2022-0685
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find out if combining pembrolizumab, bevacizumab (or an equivalent biosimilar drug), and low-dose cyclophosphamide can help control high-grade ovarian cancer that has MRD after treatment. The safety of this treatment combination will also be studied.
Detailed description
Primary Objectives
- To determine whether the combination of pembrolizumab, bevacizumab (or equivalent biosimilars) and oral low dose cyclophosphamide can improve PFS by 6 months (compared to historical control/current trial) in patients with high grade ovarian cancer with residual disease identified by second look laparoscopy.
Secondary Objectives
- To determine the safety of the above regimen in this patient population.
Exploratory Objectives
- Correlating clinical benefit with gene expression and immune profiles of tumor tissue from SLL and confirmatory biopsy at the time of radiological progression.
- Tumor cell free tumor DNA (ctDNA) is emerging as a potentially sensitive marker of response in patients undergoing immunotherapy treatment(Lee et al. 2018). We will compare serial plasma ctDNA levels with response by RECIST v1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide | Experimental | Drug: Pembrolizumab, Drug: Bevacizumab, Drug: CyclophosphamideParticipants will begin receiving the study drug Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide. Each study cycle is 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of high grade non-mucinous epithelial ovarian cancer will be enrolled in this study.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- The participant provides written informed consent for the trial.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- Have received standard of care frontline surgical and chemotherapy treatment (at least six cycles of platinum and taxane (or equivalent, with or without bevacizumab/biosimilar therapy). Patients who received neoadjuvant therapy are included. Omission of one or more doses of chemo for toxicity or hypersensitivity reaction is allowed. Have minimal residual disease (MRD) after a complete clinical response to frontline therapy (defined as: having a normalization of CA-125 and no obvious evidence of disease on exam or imaging unless the patient has an elevated CA-125 thought to be due to other confounding causes by the treating physician). Imaging with subtle or indeterminate findings will not disqualify participation.
Key exclusion criteria (24 listed)
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Is currently receiving or has received an investigational agent within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Steroids to reduce risk of radiologic contrast allergy is permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KEYTRUDA®Given by IV (vein) | Drug | Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide |
| BevacizumabAlso: Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGFGiven by IV (vein) | Drug | Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide |
| CyclophosphamideAlso: Cytoxan®, Neosar®Given by mouth | Drug | Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amir Jazaeri, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Bevacizumab and Cyclophosphamide in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amir Jazaeri, MD ((713) 745-1613, aajazaeri@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.