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A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

Status
Active
Cancer Type
Trial Phase
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT03914612
Protocol IDs
NRG-GY018 (primary)
NRG-GY018
NCI-2019-02186
Study Sponsor
NRG Oncology

Summary

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin, works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

Objectives

PRIMARY OBJECTIVES:
I. To evaluate the efficacy of pembrolizumab in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer.

SECONDARY OBJECTIVES:
I. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) for each treatment arm.
II. To evaluate the objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in patients who enter the study with measurable disease.
III. To evaluate the duration of response (DOR) in patients who enter the study with measurable disease.
IV. To evaluate the effect of pembrolizumab on OS in patients with proficient mismatch repair (pMMR) or deficient mismatch repair (dMMR).
V. To determine whether the addition of pembrolizumab to standard combination chemotherapy is associated with improved patient reported physical function as measured with the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function scale (short form), quality of life as measured with the Functional Assessment of Cancer Therapy-Endometrial (FACT-En) Trial Outcome Index (TOI) and worsened fatigue as measured with the PROMIS-Fatigue scale (short form) in the pMMR patients.
VI. To determine concordance between institutional MMR immunohistochemistry (IHC) testing and centralized MMR IHC.

EXPLORATORY OBJECTIVES:
I. To explore the correlation between patient-reported physical function as measured with the PROMIS-physical function scale (short form) and quality of life as measure with the FACT-En TOI.
II. To explore whether the addition of pembrolizumab to standard combination chemotherapy is associated with self-reported neurotoxicity as measured with the FACT/Gynecologic Oncology Group Neurotoxicity (GOG-Ntx) subscale (short) and the extent to which patients differ on their self-reported bother from side effects of cancer therapy in the pMMR patients.
III. To evaluate the efficacy of pembrolizumab in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer by PD-L1 IHC (positive vs negative).
IV. To assess the association between PD-L1 IHC (positive vs negative) and mismatch repair status (pMMR and dMMR).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I:
COMBINATION PHASE: Patients receive placebo intravenously (IV) over 30 minutes on day 1, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Patients with stable disease (SD) or partial response (PR) who still have measurable disease receive placebo IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 29 cycles in the absence of disease progression or unacceptable toxicity.

ARM II:
COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Patients with SD or PR who still have measurable disease receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 29 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta


3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
770-777-1315
www.atlantacancercare.com

Atlanta Cancer Care - Conyers


1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Cumming


1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041
www.atlantacancercare.com

Atlanta Cancer Care - Decatur


2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Atlanta Cancer Care - Stockbridge


7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Atlanta Cancer Care - Tower


5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com

Atlanta Gynecologic Oncology


980 Johnson Ferry Road
Suite 900
Atlanta, GA 30342
404-303-3355
www.geraldfeuer.com

Georgia Cancer Specialists - Athens


125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com

Georgia Cancer Specialists - Canton


228 Riverstone Drive
Canton, GA 30114
www.gacancer.com

Georgia Cancer Specialists - CenterPointe


1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Georgia Cancer Specialists - Kennestone


790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com

Georgia Cancer Specialists - Macon-Coliseum


308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Georgia Cancer Specialists - Stemmer


2712 Lawrenceville Highway
Decatur, GA 30033
770-496-5555
www.gacancer.com

Georgia Gynecologic Oncology


980 Johnson Ferry Road
Suite 910
Atlanta, GA 30342
404-303-3355
www.ggo-atl.com/

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Northside Hospital Cancer Institute - Forsyth


1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041
404-303-3355
www.northside.com

University Gynecologic Oncology


960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342
404-303-3355
www.ugynonc.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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