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Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid Tumors

Status
Active
Cancer Type
Bladder Cancer
Lung Cancer
Melanoma
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03637803
Protocol IDs
MRx0518-I-002 (primary)
NCI-2019-02944
Keynote MK3475-823
Study Sponsor
4D pharma plc

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).

Eligibility

  1. Willing and able to provide written informed consent/assent for the trial.
  2. =18 years of age on day of signing informed consent.
  3. Histological or cytological evidence of advanced and/or metastatic or recurrent NSCLC, renal cell carcinoma, bladder cancer or melanoma.
  4. At least one measurable lesion per RECIST v 1.1 criteria.
  5. Failure to respond or intolerance to standard therapy or for whom no appropriate therapies are known to provide clinical benefit (per the judgement of the Investigator).
  6. Subjects must have progressed on treatment with a PD-1/PD-L1 inhibitor administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1/PD-L1 inhibitor treatment progression is defined by meeting all of the following criteria:
  7. Has received at least 2 doses of a PD-1/PD-L1 inhibitor.
  8. Has demonstrated disease progression after PD-1/PD-L1 therapy as defined by RECIST v1.1, iRECIST or irRECIST. The initial evidence of disease progression (PD) is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression.
  9. Progressive disease has been documented within 12 weeks from the last dose of a PD-1/PD-L1 inhibitor.
  10. Have adequate organ function
  11. Be willing to provide archival tissue
  12. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  13. Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for =2 years.
  14. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
  15. Male subjects with female partners of childbearing potential should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.