NCT03192059

Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer

A Phase II Investigation of Pembrolizumab (Keytruda) in Combination With Radiation and an Immune Modulatory Cocktail in Patients With Cervical and Uterine Cancer (PRIMMO Trial)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II study in patients with advanced and/refractory cervical cancer, endometrial carcinoma or uterine sarcoma. Patients will be treated with an immunomodulatory cocktail (Vitamin D, aspirin, Cyclophosphamide and Lansoprazole), followed by pembrolizumab, combined with radiation. In addition, patients will take Curcumin, a food supplement.

Detailed description

This is a Phase II multi-center, open-label, non-randomized, 3-cohort study in patients with advanced and/or refractory cervical cancer, endometrial carcinoma or uterine sarcoma. Patients will be treated by an immunomodulatory cocktail (consisting of a daily intake of 2000 IU Vitamin D, 325 mg aspirin, 50 mg Cyclophosphamide and 180 or 30 mg Lansoprazole alternating weekly), followed by pembrolizumab administered intravenously at 200 mg in 21-day treatment cycles, combined with radiation (3x 8Gy in 48h-intervals). In addition, patients will take Curcumin, a food supplement on a daily basis.

Conditions

• Cervical Cancer
• Endometrial Cancer
• Uterine Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Efficacy of the combined treatment
RADIATION	Radiation	Efficacy of the combined treatment
DRUG	Vitamin D	Efficacy of the combined treatment
DRUG	Aspirin	Efficacy of the combined treatment
DRUG	Lansoprazole	Efficacy of the combined treatment
DRUG	Cyclophosphamide	Efficacy of the combined treatment
DIETARY_SUPPLEMENT	Curcumin	Efficacy of the combined treatment

Timeline

• Start date: 2017-07-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2017-06-19
• Last updated: 2021-09-08

Locations

4 sites across 1 country: Belgium