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

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 2

Conditions

Endometrial Cancer

Uterine Cancer

Cervical Cancer

Treatments

Drug: Aspirin

Drug: Pembrolizumab

Drug: Cyclophosphamide

Drug: Lansoprazole

Radiation: Radiation

Dietary Supplement: Curcumin

Drug: Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT03192059

2016-001569-97

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have histologically confirmed endometrial carcinoma, cervical carcinoma or uterine sarcoma, refractory or persistent to chemotherapy or recurrent disease after at least one line of chemotherapy.
Presence of an index lesion amenable to hypofractionated stereotactic radiotherapy
At least one lesion outside the radiation field that can be followed by imaging for clinical response according to RECIST and irRC
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion before and after radiotherapy if technically feasible.
Have a performance status of 0 or 1 or 2 on the ECOG Performance Scale.
Demonstrate adequate organ function

Exclusion criteria

Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agent
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of trial treatment,
Known history of active TB (Bacillus Tuberculosis), Human Immunodeficiency Virus (HIV), HTLV or syphilis,non-infectious pneumonitis, has active autoimmune disease.
Has active central nervous system metastases and/or carcinomatous meningitis