Fact CheckerSign in

NCT04317066CompletedPhase 1

A Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-A33/KEYNOTE-A33)

A Phase 1 Clinical Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (KEYNOTE-A33)

Source: ClinicalTrials.gov · Last updated 6 Apr 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the objective response, safety, and tolerability of pembrolizumab in Japanese participants who have refractory primary mediastinal large B-cell lymphoma.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
7 (actual)
First submitted
19 Mar 2020
Start date
26 Jun 2020
Primary completion date
11 Apr 2024
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT04317066

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 7
  • From 26 Jun 2020 to the primary completion date, 11 Apr 2024
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received chimeric antigen receptor (CAR) T-cell therapy
  • 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
  • Major surgery within 3 weeks prior to first dose of study intervention
  • Received a live vaccine within 30 days prior to the first dose of study drug
  • 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
  • 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
  • Allogeneic hematopoietic stem cell/solid organ transplantation within the last 5 years

Other illness

  • 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
  • Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
  • Active autoimmune disease that has required systemic treatment in past 2 years
  • History of (non-infectious) pneumonitis that required steroids, or current pneumonitis
  • Active infection requiring systemic therapy
  • History of human immunodeficiency virus (HIV) or Hepatitis B
  • Active Hepatitis C virus infection
  • Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Lab values

  • 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 \[cluster of differentiation 137\])

Other

  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention

Who the study is looking for

  • Diagnosis of Primary mediastinal B-cell lymphoma (PMBCL)
  • Relapsed or refractory PMBCL and:
    • Relapsed after auto-stem cell transplantation (SCT) or have failed to achieve a complete response (CR) or partial response (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
  • Previously exposed to rituximab as part of prior lines of treatment
  • Radiographically measurable disease
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • Life expectancy ≥3 months
  • Adequate organ function
  • Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug, OR must be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
  • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug OR must be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kyushu University Hospital ( Site 0008)
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Nagoya University Hospital ( Site 0002)
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Okayama University Hospital ( Site 0004)
Coordinator of this site? Confirm its status
OkayamaJapanUnknown status
Hokkaido University Hospital ( Site 0006)
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Kindai University Hospital ( Site 0001)
Coordinator of this site? Confirm its status
SayamaJapanUnknown status
National Hospital Organization Disaster Medical Center ( Site 0007)
Coordinator of this site? Confirm its status
TachikawaJapanUnknown status
National Cancer Center Hospital ( Site 0005)
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Tokyo Metropolitan Komagome Hospital ( Site 0009)
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Yamagata University Hospital ( Site 0003)
Coordinator of this site? Confirm its status
YamagataJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.