Triple Drug Combo for Advanced Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Amir A. Jazaeri

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunodeficiency, Active infection, Autoimmune, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving certain treatments like systemic chemotherapy, biological therapy, or radiation therapy. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug combination Bevacizumab, Cyclophosphamide, and Pembrolizumab for advanced ovarian cancer?

Bevacizumab has shown positive effects in treating ovarian cancer, especially when used with chemotherapy, as seen in large trials. It is also approved for use in combination with other drugs for platinum-resistant ovarian cancer, indicating its potential effectiveness in challenging cases. ^{1 2 3 4 5}

What safety data exists for the triple drug combo treatment for advanced ovarian cancer?

Bevacizumab, one of the drugs in the combo, has been studied for safety in ovarian cancer and is generally well-tolerated, but it can cause mild side effects like high blood pressure and protein in the urine, and rare serious effects like blood clots and bowel perforation. Pembrolizumab has been evaluated for safety in advanced ovarian cancer, showing it is generally safe, but specific side effects were not detailed in the available research. ^{6 7 8 9 10}

What makes the triple drug combo for advanced ovarian cancer unique?

The triple drug combo for advanced ovarian cancer is unique because it combines bevacizumab, cyclophosphamide, and pembrolizumab, which target different aspects of cancer growth and immune response. Bevacizumab inhibits blood vessel growth in tumors, cyclophosphamide is a chemotherapy drug that kills cancer cells, and pembrolizumab is an immunotherapy that helps the immune system attack cancer cells, offering a novel approach compared to standard platinum-based therapies. ^{1 11 12 13 14}

Research Team

Amir A. Jazaeri

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women over 18 with high-grade non-mucinous ovarian cancer, who've had surgery and chemo but still have minimal residual disease. They must not have BRCA mutations or HRD-positive tumors, need good organ function, no recent vaccines or other treatments, and can't be pregnant.

Inclusion Criteria

I am a woman over 18 with a specific type of ovarian cancer.

I had surgery to check for cancer after initial treatment was successful.

I have recovered from my recent surgery and am ready to start a new treatment.

Exclusion Criteria

I have not received a live vaccine in the last 30 days.

I have another cancer that has been treated or progressed in the last 3 years.

I have or had lung inflammation that needed steroids.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pembrolizumab in combination with Bevacizumab and Oral Cyclophosphamide. Each study cycle is 21 days.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Cyclophosphamide (Alkylating agents)
• Pembrolizumab (Checkpoint Inhibitor)

Trial Overview The study tests a combination of pembrolizumab (an immunotherapy), bevacizumab (a drug that inhibits blood vessel growth in tumors), and low-dose cyclophosphamide (a chemotherapy) to see if it controls ovarian cancer better after standard treatment.

Participant Groups

Group I: Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide Experimental Treatment 3 Interventions

Participants will begin receiving the study drug Pembrolizumab in Combination with Bevacizumab and Oral Cyclophosphamide. Each study cycle is 21 days.

Bevacizumab is already approved in Japan, Canada for the following indications:

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative therapies for advanced ovarian cancer. Trimble, EL.[2012]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal first-line treatment in ovarian cancer. Raja, FA., Chopra, N., Ledermann, JA.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimal therapeutic strategies in ovarian epithelial cancer in 1997]. Piccart, MJ., Nogaret, JM.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube. Herzog, TJ., Monk, BJ., Rose, PG., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of bevacizumab in the treatment of platinum-resistant ovarian cancer: current perspectives. McClung, EC., Wenham, RM.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. Varga, A., Piha-Paul, S., Ott, PA., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with bevacizumab in the management of epithelial ovarian cancer. Burger, RA.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy. Wenham, RM., Lapolla, J., Lin, HY., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Bevacizumab Combined with Albumin-Bound Paclitaxel in the Treatment of Platinum-Resistant Recurrent Ovarian Cancer. Liu, B., An, R., Yu, J.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effect of bevacizumab combined with paclitaxel and carboplatin on recurrent ovarian cancer. Cong, J., Liu, R., Hou, J., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New aspects by the therapy of ovarian cancer--What changes after the ASCO-Meeting 2001]. Costa, SD., von Minckwitz, G., Wernicke, K., et al.[2008]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Pfisterer, J., Shannon, CM., Baumann, K., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platinum-resistant recurrent ovarian cancer with long survival on bevacizumab and gemcitabine. Komiyama, S., Kugimiya, T., Takeya, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post hoc analyses of GOG 9923: Does BRCA status affect toxicities?: An NRG oncology study. Gillen, J., Miller, A., Bell-McGuinn, KM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Innovative therapies for advanced ovarian cancer. [2012]

2. England pubmed.ncbi.nlm.nih.gov

Optimal first-line treatment in ovarian cancer. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Optimal therapeutic strategies in ovarian epithelial cancer in 1997]. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Profile of bevacizumab in the treatment of platinum-resistant ovarian cancer: current perspectives. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Experience with bevacizumab in the management of epithelial ovarian cancer. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy. [2021]

9. Cyprus pubmed.ncbi.nlm.nih.gov

Efficacy of Bevacizumab Combined with Albumin-Bound Paclitaxel in the Treatment of Platinum-Resistant Recurrent Ovarian Cancer. [2020]

10. Cyprus pubmed.ncbi.nlm.nih.gov

Therapeutic effect of bevacizumab combined with paclitaxel and carboplatin on recurrent ovarian cancer. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

[New aspects by the therapy of ovarian cancer--What changes after the ASCO-Meeting 2001]. [2008]

12. England pubmed.ncbi.nlm.nih.gov

Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. [2022]

13. Australia pubmed.ncbi.nlm.nih.gov

Platinum-resistant recurrent ovarian cancer with long survival on bevacizumab and gemcitabine. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Post hoc analyses of GOG 9923: Does BRCA status affect toxicities?: An NRG oncology study. [2022]