Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors

  • STATUS
    Recruiting
  • End date
    Mar 2, 2024
  • participants needed
    132
  • sponsor
    4D pharma plc
Updated on 2 February 2021
cancer
monoclonal antibodies
serum pregnancy test
measurable disease
carcinoma
breast cancer
lung cancer
progressive disease
hormone therapy
pembrolizumab
pd-l1
programmed cell death 1 ligand 1
cancer chemotherapy
solid tumour
solid neoplasm
bladder cancer
bladder tumor
kidney cancer
recurrent non-small cell lung cancer
lung carcinoma

Summary

This is an open label, safety and preliminary efficacy study of MRx0518 in combination with pembrolizumab in patients with solid tumours (non small cell lung cancer, renal cell carcinoma, bladder cancer or melanoma).

Subjects will be treated with IV pembrolizumab every 3 weeks and 1 capsule twice daily of MRx0518. Treatment will continue as long as clinically relevant, until disease progression, unacceptable AEs or withdrawal of consent up to a maximum of 35 cycles (approx. 2 years).

Details
Condition Non-Small Cell Lung Cancer, Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, urinary tract neoplasm, Urologic Cancer, Malignant neoplasm of kidney, Kidney Cancer, Renal Cancer, bladder cancer, bladder cancer, Bladder Carcinoma, Urothelial Cancer, bladder disorder, Bladder Disorders, melanoma, Malignant Melanoma, Metastatic Melanoma, melanoma, Renal Cell Carcinoma, Renal Cell Carcinoma, Renal Cell Cancer, skin cancer, skin cancer, Metastatic Melanoma, Solid Tumors, Solid Tumor, Solid Neoplasm, Urothelial Cancer, Oncology, Solid Tumour, Kidney Cancer, Malignant Melanoma, Malignant Adenoma, Bladder Disorders, Renal Cell Cancer, Renal Cancer, Bladder Carcinoma, Urologic Cancer, clear cell renal cell carcinoma, carcinoma of the bladder, nsclc, bladder tumor
Treatment Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA], MRx0518
Clinical Study IdentifierNCT03637803
Sponsor4D pharma plc
Last Modified on2 February 2021

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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