JPRN-jRCT2080225167
Completed
Phase 1
A Phase 1 Clinical Study of Pembrolizumab (MK-3475) in Participants with Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (KEYNOTE-A33)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MSD K.K.
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Diagnosis of Primary mediastinal B\-cell lymphoma (PMBCL)
- •2\.Relapsed or refractory PMBCL and:
- •Relapsed after auto\-stem cell transplantation (SCT) or have failed to achieve a CR or PR within 60 days of auto\-SCT; or
- •For participants who are ineligible for auto\-SCT, has received at least \>\= 2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. For participants who received consolidative local radiotherapy after systemic therapy, local radiotherapy will not be considered as a separate line of treatment.
- •3\.Previously exposed to rituximab as part of prior lines of treatment.
- •4\.Radiographically measurable disease
- •5\.Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •6\.Life expectancy \>\=3 months.
- •7\.Adequate organ function.
- •8\. Is male or female, at least 18 years of age at the time of signing the informed consent.
Exclusion Criteria
- •1\.Received prior therapy with an anti\-PD\-1 (programmed cell death protein 1\), anti\-PD\-L1 (programmed death\-ligand 1\), or anti\-PD\-L2 (programmed cell death 1 ligand 2\), or with an agent directed to another stimulatory or co\-inhibitory T\-cell receptor (e.g., CTLA\-4 \[cytotoxic T\-lymphocyte\-associated protein 4], OX 40, or CD137 \[cluster of differentiation 137])
- •2\.Received chimeric antigen receptor (CAR) T\-cell therapy.
- •3\.Prior monoclonal antibody or radiation therapy within 4 weeks prior to the first dose of study intervention; OR received prior chemotherapy or targeted small molecule therapy within 2 weeks prior to the first dose of study intervention; OR has not recovered from adverse events due to a previously administered agent above. Participants with \<\= Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- •4\.Major surgery within 3 weeks prior to first dose of study intervention.
- •5\.Received a live vaccine within 30 days prior to the first dose of study drug.
- •6\.Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Participants in the follow\-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- •7\.Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
- •8\.Known additional malignancy that is progressing or has required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, that have undergone potentially curative therapy.
- •9\.Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •10\.Severe hypersensitivity (\>\=Grade 3\) to pembrolizumab and/or any of its excipients.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
A Phase I/II trial of MK-3475 (pembrolizumab) in children's solid tumorsand lymphomaCTIS2022-501257-36-00Merck Sharp & Dohme LLC148
Active, not recruiting
Phase 1
Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.Recurrent/metastatic head and neck squamous cell carcinoma.Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-003698-41-CZMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.780
Active, not recruiting
Not Applicable
Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.EUCTR2014-003698-41-ROMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.750
Active, not recruiting
Phase 1
Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.Recurrent/metastatic head and neck squamous cell carcinoma.MedDRA version: 21.1Level: PTClassification code 10071540Term: Head and neck cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-003698-41-HUMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.825
Active, not recruiting
Phase 1
Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.EUCTR2014-003698-41-GRMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.750