Pembrolizumab for Recurrent High Grade Ovarian Serous Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Recurrent High Grade Ovarian Serous Adenocarcinoma+8 More
Pembrolizumab - Biological
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Recurrent High Grade Ovarian Serous Adenocarcinoma
  • Recurrent High Grade Fallopian Tube Serous Adenocarcinoma
  • Peritoneum
  • High Grade Ovarian Serous Adenocarcinoma
  • Fallopian Tubes

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: through study completion, an average of 1 year

Year 1
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.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab+EP
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%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

2 Treatment Groups

Cohort A (pembrolizumab, lenvatinib)
1 of 2
Cohort B (pembrolizumab, lenvatinib)
1 of 2

Experimental Treatment

16 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Cohort A (pembrolizumab, lenvatinib)Experimental Group · 2 Interventions: Pembrolizumab, Lenvatinib · Intervention Types: Biological, Drug
Cohort B (pembrolizumab, lenvatinib)Experimental Group · 2 Interventions: Pembrolizumab, Lenvatinib · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,783 Previous Clinical Trials
1,784,842 Total Patients Enrolled
1 Trials studying Recurrent High Grade Ovarian Serous Adenocarcinoma
27 Patients Enrolled for Recurrent High Grade Ovarian Serous Adenocarcinoma
Amir A JazaeriPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
382 Total Patients Enrolled
1 Trials studying Recurrent High Grade Ovarian Serous Adenocarcinoma
27 Patients Enrolled for Recurrent High Grade Ovarian Serous Adenocarcinoma

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with histologically confirmed diagnosis of high grade serous ovarian cancer, peritoneal cancer, or fallopian tube cancer, and who are platinum resistant, 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
A woman who agrees to use contraception while participating in the study and for five months after the last dose of study medication.
People with blood pressure less than or equal to 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the start of treatment are considered to have adequately controlled blood pressure.
There is evidence of cancer that can be seen or measured using RECIST v1.1, and the cancer is found in the peritoneal cavity or in the lymph nodes near the peritoneal cavity
The participant must be able to understand the information in the informed consent form, and must agree to sign it before beginning the study
People who are willing to have a port placed in their abdomen for drawing fluid and blood samples are scheduled.
An absolute neutrophil count (ANC) of at least 1500/uL, taken within 10 days prior to the start of study treatment, is required.
People who are 18 years or older can participate in the study.
You have an ECOG performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
M D Anderson Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. M D Anderson Cancer Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email100.0%