TPIV200/huFR-1 (A Multi-Epitope Anti-Folate Receptor Vaccine) Plus Anti-PD-L1 MEDI4736 (Durvalumab) in Patients With Platinum Resistant Ovarian Cancer

• ClinicalTrials.gov Identifier: NCT02764333
• Recruitment Status: Completed
• First Posted: May 6, 2016
• Results First Posted: November 30, 2021
• Last Update Posted: November 30, 2021
• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: AstraZeneca; Marker Therapeutics, Inc.
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ovarian Cancer
• Interventions: Biological: TPIV200; Biological: Durvalumab
• Enrollment: 29

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Vaccine
Arm/Group Description	Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination. TPIV200 Durvalumab
Period Title: Overall Study
Started	29
Completed	28
Not Completed	1
Reason Not Completed
Ineligible	1

Baseline Characteristics

Arm/Group Title		Vaccine
Arm/Group Description		Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination. TPIV200 Durvalumab
Overall Number of Baseline Participants		29
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	29 participants
		64; (42 to 76)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants
	Female	29 100.0%
	Male	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants
	Hispanic or Latino	2 6.9%
	Not Hispanic or Latino	27 93.1%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants
	American Indian or Alaska Native	0 0.0%
	Asian	2 6.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	26 89.7%
	More than one race	0 0.0%
	Unknown or Not Reported	1 3.4%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	29 participants
		29 100.0%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate
Description	(CR+PR) and will be assessed by RECIST 1.1. Pre-defined deviations from RECIST will be permitted to allow select patients deemed to be benefitting from treatment to receive continued therapy.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaccine
Arm/Group Description:	Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination. TPIV200 Durvalumab
Overall Number of Participants Analyzed	29
Measure Type: Count of Participants; Unit of Measure: Participants
Partial Response	1 3.4%
Stable Disease	6 20.7%
Progression of Disease	4 13.8%
Not Entered	18 62.1%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Vaccine
Arm/Group Description	Patients will receive an intradermal (ID) injection of TPIV200 (500 μg per peptide) and GM-CSF (125 μg per peptide) on Day 1 of cycles 1-6. They will also receive intravenous (IV) injections of durvalumab (750mg) on Days 1 and 15 of cycles 1-12. Radiologic tumor assessment will be repeated every 12 weeks (or 3 cycles) during and after treatment, until time of progression. Treatment will continue until progression, intolerance, withdrawal, study completion, or study termination. TPIV200 Durvalumab
All-Cause Mortality
	Vaccine
	Affected / at Risk (%)
Total	4/29 (13.79%)
Serious Adverse Events
	Vaccine
	Affected / at Risk (%)
Total	9/29 (31.03%)
Gastrointestinal disorders
Colonic obstruction †	3/29 (10.34%)
General disorders
Pain †	1/29 (3.45%)
Infections and infestations
Kidney infection †	1/29 (3.45%)
Investigations
Platelet count decreased †	1/29 (3.45%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other, spec †	3/29 (10.34%)
Nervous system disorders
Stroke †	1/29 (3.45%)
Reproductive system and breast disorders
Breast pain †	1/29 (3.45%)
Respiratory, thoracic and mediastinal disorders
Dyspnea †	1/29 (3.45%)
Skin and subcutaneous tissue disorders
Rash maculo-papular †	1/29 (3.45%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Vaccine
	Affected / at Risk (%)
Total	29/29 (100.00%)
Endocrine disorders
Hyperthyroidism †	2/29 (6.90%)
Gastrointestinal disorders
Nausea †	11/29 (37.93%)
Constipation †	5/29 (17.24%)
Abdominal pain †	4/29 (13.79%)
Gastroesophageal reflux disease †	4/29 (13.79%)
Diarrhea †	3/29 (10.34%)
Vomiting †	3/29 (10.34%)
Bloating †	2/29 (6.90%)
General disorders
Injection site reaction †	11/29 (37.93%)
Fatigue †	8/29 (27.59%)
Infections and infestations
Bladder infection †	2/29 (6.90%)
Investigations
Serum amylase increased †	3/29 (10.34%)
Lipase increased †	2/29 (6.90%)
Metabolism and nutrition disorders
Anorexia †	2/29 (6.90%)
Musculoskeletal and connective tissue disorders
Back pain †	3/29 (10.34%)
Myalgia †	3/29 (10.34%)
Arthralgia †	2/29 (6.90%)
Respiratory, thoracic and mediastinal disorders
Dyspnea †	8/29 (27.59%)
Cough †	4/29 (13.79%)
Skin and subcutaneous tissue disorders
Rash maculo-papular †	5/29 (17.24%)
Pruritus †	3/29 (10.34%)
Rash acneiform †	2/29 (6.90%)
† 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

• Name/Title: Dr. Jason Konner, MD
• Organization: Memorial Sloan Kettering Cancer Center
• Phone: 848-225-6530
• EMail: konnerj@MSKCC.ORG

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT02764333
• Other Study ID Numbers: 16-011
• First Submitted: May 4, 2016
• First Posted: May 6, 2016
• Results First Submitted: November 1, 2021
• Results First Posted: November 30, 2021
• Last Update Posted: November 30, 2021