Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL (NCT03240211) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL
United States37 participantsStarted 2022-02-02
Plain-language summary
This is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation study. The primary objectives of the study in each arm is to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate the clinical efficacy at the MTD of various combinations of pembrolizumab, pralatrexate and decitabine.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent/assent for the trial.
✓. Be ≥ 18 years of age on day of signing informed consent.
✓. Have measurable disease as defined by the Lugano Criteria for PTCL and by the Global Response Score for CTCL.
✓. Patient must have histologically confirmed relapsed or refractory Peripheral T-cell lymphoma (PTCL) or cutaneous T-cell Lymphoma (CTCL) as per WHO criteria and TNMB classification and staging.
✓. There is no upper limit for the number of prior therapies. Patient may have relapsed after prior autologous stem cell transplant.
✓. Patients who had prior treatment for their disease, as long as there is radiographic evidence of refractory or relapsed disease and the patient meets all other clinical and laboratory criteria for study treatment.
✓. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Be willing to provide FNA of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
✓. Have a performance status of 0 or 1 on the ECOG Performance Scale.
Exclusion criteria
✕. Has lack of resolution of adverse events (AE) due to previously administered antineoplastic therapy to grade 1 or less according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
✕. Has a diagnosis of immunodeficiency or has been receiving any immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Use of steroid equivalent to prednisone 10 mg/day does not constitute an exclusion criterion.
✕. Has a known history of active TB (Bacillus Tuberculosis)
✕. Hypersensitivity to pralatrexate, or decitabine or pembrolizumab or any of its excipients.
✕. Has received prior allogeneic stem cell transplant.
✕. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
✕. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.