Trial Outcomes & Findings for TPIV200/huFR-1 (A Multi-Epitope Anti-Folate Receptor Vaccine) Plus Anti-PD-L1 MEDI4736 (Durvalumab) in Patients With Platinum Resistant Ovarian Cancer (NCT NCT02764333)

NCT ID: NCT02764333

Last Updated: 2021-11-30

Results Overview

(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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2021-11-30

Participant Flow

Participant milestones

Measure	Vaccine 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 Study STARTED	29
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Vaccine 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 Study Ineligible

1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Vaccine n=29 Participants 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
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

(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.

Outcome measures

Measure	Vaccine n=29 Participants 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 Response Rate Partial Response	1 Participants
Overall Response Rate Stable Disease	6 Participants
Overall Response Rate Progression of Disease	4 Participants
Overall Response Rate Not Entered	18 Participants

Adverse Events

Vaccine

Serious events: 9 serious events

Other events: 29 other events

Deaths: 4 deaths

Serious adverse events

Measure	Vaccine n=29 participants at risk 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
Reproductive system and breast disorders Breast pain	3.4% 1/29 • 1 year
Gastrointestinal disorders Colonic obstruction	10.3% 3/29 • 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	3.4% 1/29 • 1 year
Infections and infestations Kidney infection	3.4% 1/29 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other, spec	10.3% 3/29 • 1 year
General disorders Pain	3.4% 1/29 • 1 year
Investigations Platelet count decreased	3.4% 1/29 • 1 year
Skin and subcutaneous tissue disorders Rash maculo-papular	3.4% 1/29 • 1 year
Nervous system disorders Stroke	3.4% 1/29 • 1 year

Other adverse events

Measure	Vaccine n=29 participants at risk 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
General disorders Injection site reaction	37.9% 11/29 • 1 year
Gastrointestinal disorders Nausea	37.9% 11/29 • 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	27.6% 8/29 • 1 year
General disorders Fatigue	27.6% 8/29 • 1 year
Gastrointestinal disorders Constipation	17.2% 5/29 • 1 year
Skin and subcutaneous tissue disorders Rash maculo-papular	17.2% 5/29 • 1 year
Gastrointestinal disorders Abdominal pain	13.8% 4/29 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	13.8% 4/29 • 1 year
Gastrointestinal disorders Gastroesophageal reflux disease	13.8% 4/29 • 1 year
Musculoskeletal and connective tissue disorders Back pain	10.3% 3/29 • 1 year
Gastrointestinal disorders Diarrhea	10.3% 3/29 • 1 year
Musculoskeletal and connective tissue disorders Myalgia	10.3% 3/29 • 1 year
Skin and subcutaneous tissue disorders Pruritus	10.3% 3/29 • 1 year
Investigations Serum amylase increased	10.3% 3/29 • 1 year
Gastrointestinal disorders Vomiting	10.3% 3/29 • 1 year
Metabolism and nutrition disorders Anorexia	6.9% 2/29 • 1 year
Musculoskeletal and connective tissue disorders Arthralgia	6.9% 2/29 • 1 year
Infections and infestations Bladder infection	6.9% 2/29 • 1 year
Gastrointestinal disorders Bloating	6.9% 2/29 • 1 year
Endocrine disorders Hyperthyroidism	6.9% 2/29 • 1 year
Investigations Lipase increased	6.9% 2/29 • 1 year
Skin and subcutaneous tissue disorders Rash acneiform	6.9% 2/29 • 1 year

Additional Information

Dr. Jason Konner, MD

Memorial Sloan Kettering Cancer Center

Phone: 848-225-6530

Email: konnerj@MSKCC.ORG

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place