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Enzyme Inhibitor

Pembrolizumab + Lenvatinib for Ovarian Cancer

Phase 2

Waitlist Available

Led By Amir A Jazaeri

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Participants willing to undergo intraperitoneal port placement and scheduled peritoneal fluid and peripheral blood draws

Must not have

Active autoimmune disease that has required systemic treatment in the past 2 years

Active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of two drugs, pembrolizumab and lenvatinib, on patients with high-grade serous ovarian cancer. The drugs work in different ways to attack the cancer cells, and it is hoped that they will be more effective together than either one alone.

Who is the study for?

This trial is for adult women with high-grade serous ovarian, fallopian tube, or peritoneal cancers that are resistant to platinum-based treatments. Participants must have controlled blood pressure, good physical function (ECOG 0-1), and measurable disease in the peritoneal cavity or lymph nodes. They should not be pregnant and must agree to follow contraceptive guidance.

What is being tested?

The trial studies pembrolizumab (an immunotherapy drug) combined with lenvatinib (an enzyme inhibitor) in treating patients. The goal is to see if this combination can help control the cancer by boosting the immune system's response and stopping cancer cell growth.

What are the potential side effects?

Possible side effects include high blood pressure, fatigue, liver issues, kidney problems, bleeding risks, gastrointestinal symptoms like diarrhea or nausea, immune-related reactions such as rash or thyroid dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am willing to have a port placed in my abdomen for treatment and agree to scheduled fluid and blood tests.

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My cancer has spread to the abdominal area or behind the stomach.

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My cancer is a high-grade serous type and does not respond to platinum-based treatments.

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My blood pressure is under control and hasn't required new medication in the last week.

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I am a woman aged 18 or older.

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My cancer is high grade serous and resistant to platinum-based treatments.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have an autoimmune disease treated with medication in the last 2 years.

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I am currently on medication for an infection.

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I have received an organ or tissue transplant from another person.

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I have active brain metastases or cancer in the lining of my brain.

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I've had a severe increase in blood pressure with previous anti-VEGF treatment.

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I have been treated with lenvatinib before.

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I have been diagnosed with HIV.

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I haven't had serious heart problems in the last year.

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I have recovered from side effects of previous treatments to my normal or mild condition.

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I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.

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I have or had lung inflammation that needed steroids.

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I have not taken immunosuppressive drugs or steroids in the last 7 days.

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I had another type of cancer but was treated successfully and have been cancer-free for 2 years.

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I recently had major surgery and haven't fully recovered.

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I have an active TB infection.

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I have a severe fistula.

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My tumor is affecting a major blood vessel or has cavities inside it.

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I have a history of chronic hepatitis B or C.

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

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B (pembrolizumab, lenvatinib)Experimental Treatment2 Interventions

Beginning cycle 0, patients receive lenvatinib PO QD on days 1-21. Beginning cycle 1, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Cohort A (pembrolizumab, lenvatinib)Experimental Treatment2 Interventions

Beginning cycle 0, patients receive pembrolizumab IV over 30 minutes on day 1. Beginning cycle 1, patients also receive lenvatinib PO QD on days 1-21. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

2017

Completed Phase 4

~2070

Pembrolizumab

2017

Completed Phase 3

~3130