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Enzyme Inhibitor

Pembrolizumab + Lenvatinib for Ovarian Cancer

Phase 2
Recruiting
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
Female participants who are at least 18 years of age.
A histology confirming diagnosis of high grade serous ovarian/peritoneal/fallopian tube cancers and platinum-resistant disease as defined as disease progression on a platinum-containing agent or recurrent within 180 days of prior dose of a platinum-containing chemotherapeutic regimen will be enrolled in this study. Pathology must have been reviewed at MD Anderson.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Study 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.Check my eligibility
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.See study design
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 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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My cancer can be measured and is present in my abdomen or lymph nodes near my spine.
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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 fully active or restricted in physically strenuous activity but can do light work.
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I can understand and am willing to sign the consent form before starting the study.
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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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I am fully active or can carry out 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 is a high-grade serous type and does not respond to platinum-based treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the proportion of CD8+ and CD4+ cells that are Ki67+ at the monotherapy phase in comparison to the combination therapy phase of treatment.
Change in the proportion of CD8+ and CD4+ cells that are PD1+CD38+ at the monotherapy phase in comparison to the combination therapy phase of treatment.

Side effects data

From 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Upper respiratory tract infection
8%
Pneumonia
8%
Oedema peripheral
8%
Alanine aminotransferase increased
7%
Hypokalaemia
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Nasopharyngitis
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Pulmonary embolism
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

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
2005
Completed Phase 4
~2700
Pembrolizumab
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,945 Previous Clinical Trials
1,803,351 Total Patients Enrolled
Amir A JazaeriPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
278 Total Patients Enrolled

Media Library

Lenvatinib (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05114421 — Phase 2
Peritoneal Carcinoma Research Study Groups: Cohort A (pembrolizumab, lenvatinib), Cohort B (pembrolizumab, lenvatinib)
Peritoneal Carcinoma Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT05114421 — Phase 2
Lenvatinib (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05114421 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What illnesses or conditions does Pembrolizumab target?

"While most often used to treat malignant neoplasms, Pembrolizumab has also proven effective in managing unresectable melanoma, microsatellite instability high, and chemotherapy-induced disease progression."

Answered by AI

What is the evidence for Pembrolizumab's effectiveness?

"Out of the 1076 ongoing clinical trials involving Pembrolizumab, 134 of them are in Phase 3. The largest numbers of these studies are situated in Sacramento, California; however, there are a total 37375 locations running clinical trials for Pembrolizumab around the world."

Answered by AI

How many study participants are involved in this research project?

"Yes, according to the latest information available on clinicaltrials.gov, this trial is still looking for volunteers. The posting went up on November 9th, 2021 and was last updated July 9th, 2022. Right now, they are trying to fill 16 spots at a single location."

Answered by AI

Has Pembrolizumab been given the green light by the FDA?

"Pembrolizumab's efficacy has not been proven, but there is some data suggesting that it may be safe. Our team at Power gives it a score of 2."

Answered by AI

Is this clinical trial still looking for new participants?

"The clinicaltrials.gov website says that this trial is still looking for participants. The listing was created on November 9th, 2021 and updated on July 9th, 2022. They need 16 people to join and the trial will be conducted at 1 site."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. M D Anderson Cancer Center: < 48 hours
~9 spots leftby Jan 2025