A Study of Durvalumab With or Without Tremelimumab in Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT03015129

Recruitment Status : Completed

First Posted : January 9, 2017

Results First Posted : February 6, 2024

Last Update Posted : February 6, 2024

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Sponsor:

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Endometrial Cancer Endometrial Carcinosarcoma Endometrial Carcinoma Endometrial Cancer Recurrent Endometrial Carcinoma, Recurrent
Interventions	Drug: Durvalumab Drug: Tremelimumab
Enrollment	80

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Durvalubmab	Durvalubmab + Tremelimumab
Arm/Group Description	Patients will receive intravenous i...	Patients will receive 1500mg Flat D...
Arm/Group Description	Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities. Durvalumab	Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities. Durvalumab Tremelimumab
Period Title: Overall Study
Started	40	40
Completed	0	0
Not Completed	40	40
Reason Not Completed
Death	2	2
Lost to Follow-up	0	1
Progression of disease	38	33
Adverse Event	0	4

Baseline Characteristics

Arm/Group Title		Durvalubmab	Durvalubmab + Tremelimumab	Total
Arm/Group Description		Patients will receive intravenous i...	Patients will receive 1500mg Flat D...	Total of all reporting groups
Arm/Group Description		Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities. Durvalumab	Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities. Durvalumab Tremelimumab	Total of all reporting groups
Overall Number of Baseline Participants		40	40	80
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	40 participants	40 participants	80 participants
		65 (45 to 78)	66 (52 to 84)	66 (45 to 84)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	40 participants	40 participants	80 participants
	Female	40 100.0%	40 100.0%	80 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	40 participants	40 participants	80 participants
	Hispanic or Latino	1 2.5%	3 7.5%	4 5.0%
	Not Hispanic or Latino	39 97.5%	37 92.5%	76 95.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	40 participants	40 participants	80 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	4 10.0%	3 7.5%	7 8.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	4 10.0%	5 12.5%	9 11.3%
	White	29 72.5%	27 67.5%	56 70.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	3 7.5%	5 12.5%	8 10.0%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
United States	Number Analyzed	40 participants	40 participants	80 participants
United States		40 100.0%	40 100.0%	80 100.0%

Outcome Measures

1.Primary Outcome


Title	Treatment Efficacy Determined by Measuring the Overall Response Rate
Description	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0...
Description	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame	Up to 72 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Durvalubmab	Durvalubmab + Tremelimumab
Arm/Group Description:	Patients will receive intravenous i...	Patients will receive 1500mg Flat D...
Arm/Group Description:	Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities. Durvalumab	Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities. Durvalumab Tremelimumab
Overall Number of Participants Analyzed	40	40
Measure Type: Number Unit of Measure: Participants
	5	4

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Durvalubmab	Durvalubmab + Tremelimumab
Arm/Group Description	Patients will receive intravenous i...	Patients will receive 1500mg Flat D...
Arm/Group Description	Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities. Durvalumab	Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities. Durvalumab Tremelimumab
All-Cause Mortality
	Durvalubmab	Durvalubmab + Tremelimumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/40 (5.00%)	2/40 (5.00%)
Serious Adverse Events Serious Adverse Events
	Durvalubmab	Durvalubmab + Tremelimumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	13/40 (32.50%)	7/40 (17.50%)
Blood and lymphatic system disorders
Leukocytosis ^†	0/40 (0.00%)	1/40 (2.50%)
Anemia ^†	1/40 (2.50%)	0/40 (0.00%)
Cardiac disorders
Atrial fibrillation ^†	0/40 (0.00%)	1/40 (2.50%)
Left ventricular systolic dysfunction ^†	1/40 (2.50%)	0/40 (0.00%)
Myocarditis ^†	1/40 (2.50%)	0/40 (0.00%)
Endocrine disorders
Adrenal insufficiency ^†	1/40 (2.50%)	0/40 (0.00%)
Hypothyroidism ^†	1/40 (2.50%)	0/40 (0.00%)
Gastrointestinal disorders
Ascites ^†	1/40 (2.50%)	1/40 (2.50%)
Abdominal Pain ^†	6/40 (15.00%)	0/40 (0.00%)
Colitis ^†	1/40 (2.50%)	0/40 (0.00%)
Colonic perforation ^†	1/40 (2.50%)	0/40 (0.00%)
Constipation ^†	1/40 (2.50%)	0/40 (0.00%)
Diarrhea ^†	6/40 (15.00%)	0/40 (0.00%)
Rectal hemorrhage ^†	1/40 (2.50%)	0/40 (0.00%)
Rectal pain ^†	1/40 (2.50%)	0/40 (0.00%)
Small intestinal obstruction ^†	2/40 (5.00%)	0/40 (0.00%)
Vomiting ^†	1/40 (2.50%)	0/40 (0.00%)
General disorders
Fatigue ^†	2/40 (5.00%)	2/40 (5.00%)
Fever ^†	3/40 (7.50%)	1/40 (2.50%)
Hypercalcemia ^†	0/40 (0.00%)	1/40 (2.50%)
Pain ^†	0/40 (0.00%)	1/40 (2.50%)
Injury, poisoning and procedural complications
Spinal fracture ^†	0/40 (0.00%)	1/40 (2.50%)
Investigations
Alanine aminotransferase increased ^†	1/40 (2.50%)	1/40 (2.50%)
Alkaline phosphatase increased ^†	1/40 (2.50%)	1/40 (2.50%)
Aspartate aminotransferase increased ^†	1/40 (2.50%)	2/40 (5.00%)
Blood bilirubin increased ^†	1/40 (2.50%)	0/40 (0.00%)
CPK increased ^†	1/40 (2.50%)	0/40 (0.00%)
Creatinine increased ^†	1/40 (2.50%)	0/40 (0.00%)
Weight Loss ^†	1/40 (2.50%)	0/40 (0.00%)
Metabolism and nutrition disorders
Hyperkalemia ^†	0/40 (0.00%)	1/40 (2.50%)
Hypoalbuminemia ^†	0/40 (0.00%)	1/40 (2.50%)
Musculoskeletal and connective tissue disorders
Back pain ^†	0/40 (0.00%)	1/40 (2.50%)
Myositis ^†	1/40 (2.50%)	0/40 (0.00%)
Nervous system disorders
Edema cerebral ^†	0/40 (0.00%)	1/40 (2.50%)
Seizure ^†	0/40 (0.00%)	1/40 (2.50%)
Stroke ^†	0/40 (0.00%)	1/40 (2.50%)
Dizziness ^†	1/40 (2.50%)	0/40 (0.00%)
Dysarthria ^†	1/40 (2.50%)	0/40 (0.00%)
Lethargy ^†	1/40 (2.50%)	0/40 (0.00%)
Muscle weakness left-sided ^†	1/40 (2.50%)	0/40 (0.00%)
Psychiatric disorders
Confusion ^†	1/40 (2.50%)	0/40 (0.00%)
Renal and urinary disorders
Acute kidney injury ^†	0/40 (0.00%)	1/40 (2.50%)
Renal and urinary disorders - Other, specify ^†	2/40 (5.00%)	0/40 (0.00%)
Reproductive system and breast disorders
Vaginal hemorrhage ^†	1/40 (2.50%)	0/40 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^†	0/40 (0.00%)	1/40 (2.50%)
Dyspnea ^†	0/40 (0.00%)	2/40 (5.00%)
Pleural effusion ^†	0/40 (0.00%)	1/40 (2.50%)
Pneumonitis ^†	1/40 (2.50%)	0/40 (0.00%)
Vascular disorders
Hematoma ^†	0/40 (0.00%)	1/40 (2.50%)
Thromboembolic event ^†	1/40 (2.50%)	0/40 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Durvalubmab	Durvalubmab + Tremelimumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	39/40 (97.50%)	38/40 (95.00%)
Blood and lymphatic system disorders
Anemia ^†	2/40 (5.00%)	0/40 (0.00%)
Leukocytosis ^†	0/40 (0.00%)	3/40 (7.50%)
Cardiac disorders
Sinus bradycardia ^†	2/40 (5.00%)	0/40 (0.00%)
Endocrine disorders
Adrenal insufficiency ^†	2/40 (5.00%)	0/40 (0.00%)
Hypothyroidism ^†	0/40 (0.00%)	4/40 (10.00%)
Gastrointestinal disorders
Abdominal distension ^†	0/40 (0.00%)	2/40 (5.00%)
Abdominal pain ^†	25/40 (62.50%)	12/40 (30.00%)
Anal pain ^†	3/40 (7.50%)	0/40 (0.00%)
Ascites ^†	2/40 (5.00%)	4/40 (10.00%)
Colitis ^†	3/40 (7.50%)	0/40 (0.00%)
Constipation ^†	12/40 (30.00%)	8/40 (20.00%)
Diarrhea ^†	22/40 (55.00%)	10/40 (25.00%)
Dry mouth ^†	3/40 (7.50%)	2/40 (5.00%)
Flatulence ^†	3/40 (7.50%)	0/40 (0.00%)
Gastroesophageal reflux disease ^†	2/40 (5.00%)	3/40 (7.50%)
Mucositis oral ^†	2/40 (5.00%)	4/40 (10.00%)
Nausea ^†	11/40 (27.50%)	15/40 (37.50%)
Small intestinal obstruction ^†	3/40 (7.50%)	0/40 (0.00%)
Vomiting ^†	10/40 (25.00%)	6/40 (15.00%)
General disorders
Edema limbs ^†	3/40 (7.50%)	2/40 (5.00%)
Fatigue ^†	26/40 (65.00%)	20/40 (50.00%)
Fever ^†	3/40 (7.50%)	6/40 (15.00%)
Non-cardiac chest pain ^†	0/40 (0.00%)	2/40 (5.00%)
Pain ^†	17/40 (42.50%)	8/40 (20.00%)
Infections and infestations
Bladder infection ^†	4/40 (10.00%)	7/40 (17.50%)
Gum infection ^†	0/40 (0.00%)	8/40 (20.00%)
Sinusitis ^†	0/40 (0.00%)	2/40 (5.00%)
Skin infection ^†	1/40 (2.50%)	2/40 (5.00%)
Upper respiratory infection ^†	2/40 (5.00%)	2/40 (5.00%)
Urinary tract infection ^†	8/40 (20.00%)	4/40 (10.00%)
Injury, poisoning and procedural complications
Fall ^†	1/40 (2.50%)	3/40 (7.50%)
Investigations
Aspartate aminotransferase increased ^†	1/40 (2.50%)	2/40 (5.00%)
Creatinine Increased ^†	0/40 (0.00%)	2/40 (5.00%)
Weight gain ^†	6/40 (15.00%)	5/40 (12.50%)
Weight loss ^†	16/40 (40.00%)	0/40 (0.00%)
Metabolism and nutrition disorders
Anorexia ^†	12/40 (30.00%)	5/40 (12.50%)
Hyperglycemia ^†	1/40 (2.50%)	2/40 (5.00%)
Hyperkalemia ^†	1/40 (2.50%)	2/40 (5.00%)
Hypomagnesemia ^†	2/40 (5.00%)	0/40 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^†	5/40 (12.50%)	11/40 (27.50%)
Back pain ^†	6/40 (15.00%)	7/40 (17.50%)
Bone pain ^†	0/40 (0.00%)	2/40 (5.00%)
Flank pain ^†	0/40 (0.00%)	2/40 (5.00%)
Generalized muscle weakness ^†	1/40 (2.50%)	2/40 (5.00%)
Myalgia ^†	3/40 (7.50%)	9/40 (22.50%)
Pain in extremity ^†	1/40 (2.50%)	4/40 (10.00%)
Nervous system disorders
Dizziness ^†	4/40 (10.00%)	9/40 (22.50%)
Headache ^†	3/40 (7.50%)	0/40 (0.00%)
Memory impairment ^†	2/40 (5.00%)	0/40 (0.00%)
Peripheral sensory neuropathy ^†	1/40 (2.50%)	3/40 (7.50%)
Psychiatric disorders
Anxiety ^†	4/40 (10.00%)	3/40 (7.50%)
Confusion ^†	2/40 (5.00%)	1/40 (2.50%)
Renal and urinary disorders
Increased Urinary Frequency ^†	6/40 (15.00%)	0/40 (0.00%)
Urinary frequency ^†	3/40 (7.50%)	2/40 (5.00%)
Urinary hesitancy ^†	0/40 (0.00%)	4/40 (10.00%)
Urinary tract pain ^†	3/40 (7.50%)	7/40 (17.50%)
Urinary urgency ^†	2/40 (5.00%)	1/40 (2.50%)
Reproductive system and breast disorders
Vaginal discharge ^†	4/40 (10.00%)	1/40 (2.50%)
Vaginal hemorrhage ^†	2/40 (5.00%)	3/40 (7.50%)
Vaginal yeast ^†	0/40 (0.00%)	2/40 (5.00%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis ^†	0/40 (0.00%)	2/40 (5.00%)
Cough ^†	6/40 (15.00%)	3/40 (7.50%)
Dyspnea ^†	8/40 (20.00%)	10/40 (25.00%)
Epistaxis ^†	0/40 (0.00%)	2/40 (5.00%)
Nasal congestion ^†	4/40 (10.00%)	4/40 (10.00%)
Pleural effusion ^†	1/40 (2.50%)	3/40 (7.50%)
Pneumonitis ^†	2/40 (5.00%)	0/40 (0.00%)
Sore throat ^†	0/40 (0.00%)	2/40 (5.00%)
Skin and subcutaneous tissue disorders
Dry skin ^†	3/40 (7.50%)	3/40 (7.50%)
Pruritus ^†	11/40 (27.50%)	11/40 (27.50%)
Rash acneiform ^†	2/40 (5.00%)	0/40 (0.00%)
Rash maculo-papular ^†	7/40 (17.50%)	6/40 (15.00%)
Vascular disorders
Hematoma ^†	0/40 (0.00%)	2/40 (5.00%)
Hot flashes ^†	3/40 (7.50%)	0/40 (0.00%)
Hypertension ^†	14/40 (35.00%)	3/40 (7.50%)
Lymphedema ^†	2/40 (5.00%)	0/40 (0.00%)
Thromboembolic event ^†	3/40 (7.50%)	4/40 (10.00%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Vicky Makker, MD
Organization:	Memorial Sloan Kettering Cancer Center
Phone:	646-888-4224
EMail:	makkerv@mskcc.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Antill Y, Kok PS, Robledo K, Yip S, Cummins M, Smith D, Spurdle A, Barnes E, Lee YC, Friedlander M, Baron-Hay S, Shannon C, Coward J, Beale P, Goss G, Meniawy T, Lombard J, Andrews J, Stockler MR, Mileshkin L; Australia New Zealand Gynaecological Oncology Group (ANZGOG). Clinical activity of durvalumab for patients with advanced mismatch repair-deficient and repair-proficient endometrial cancer. A nonrandomized phase 2 clinical trial. J Immunother Cancer. 2021 Jun;9(6):e002255. doi: 10.1136/jitc-2020-002255.

Layout table for additonal information

Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT03015129
Other Study ID Numbers:	16-1491
First Submitted:	January 4, 2017
First Posted:	January 9, 2017
Results First Submitted:	December 6, 2023
Results First Posted:	February 6, 2024
Last Update Posted:	February 6, 2024

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