Triple-Drug Combo for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byFloor Backes, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Floor Backes, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II clinical trial studies the effect of lenvatinib, pembrolizumab, and paclitaxel in treating patients with endometrial, epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). While all 3 study drugs are FDA approved, and 2-drug combinations have been studied, the 3- drug combination has not been studied yet. The investigators believe that the addition of pembrolizumab to weekly paclitaxel and lenvatinib (or weekly paclitaxel to pembrolizumab and lenvatinib) is highly effective and safe with manageable side effects in both recurrent endometrial and platinum resistant ovarian cancer. The purpose of this trial is to study how well lenvatinib, pembrolizumab, and weekly paclitaxel work together in women who have recurrent endometrial cancer and/or recurrent platinum resistant ovarian, fallopian tube, and primary peritoneal cancer, and what kind of side effects patients may experience.

Eligibility Criteria

This trial is for women at least 18 years old with recurrent endometrial, ovarian, fallopian tube, or primary peritoneal cancer who have had platinum-based treatment. They must not be pregnant or breastfeeding and should have an acceptable organ function. Prior treatments are allowed under certain conditions but no recent severe side effects from similar drugs.

Inclusion Criteria

My ovarian, fallopian tube, or peritoneal cancer is resistant to platinum-based treatments.

Your hemoglobin level is at least 9.0 g/dL or 5.6 mmol/L within the last 10 days before starting the study treatment.

Your kidney function should be measured according to the hospital's usual method.

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Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

I have had a bowel blockage or currently have a partial blockage or a PEG-tube.

I have had pneumonitis treated with steroids or have it now.

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Treatment Details

Interventions

Lenvatinib (Tyrosine Kinase Inhibitor)
Paclitaxel (Mitotic Inhibitor)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe study tests a combination of three FDA-approved drugs: Lenvatinib, Pembrolizumab, and Paclitaxel in patients with specific recurrent cancers. The goal is to determine the effectiveness and safety of this triple-drug regimen which has not been studied before.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (paclitaxel, lenvatinib, pembrolizumab)Experimental Treatment3 Interventions

Patients receive paclitaxel IV over 1 hour on days -15 and -8 and lenvatinib PO QD on days -15 to 0. Beginning cycle 1 day 1, patients receive lenvatinib PO QD, pembrolizumab IV over 30 minutes on day 1, and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles with pembrolizumab repeats every 3 weeks for up to 2 years, and cycles with paclitaxel and lenvatinib repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Lenvatinib is already approved in United States, European Union, European Union for the following indications:

🇺🇸 Approved in United States as Lenvima for: