Phase 1 Study of MK-3475 in participants with rrPMBCL

JRCT ID: jRCT2080225167

Registered date:20/04/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Primary Mediastinal Large B-cell Lymphoma
• Date of first enrollment: 30/06/2020
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : MK-3475
INN of investigational material : pembrolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : -
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

Safety
Efficacy
-Objective response [complete response (CR) or partial response (PR)] assessed by independent central review
-Safety and tolerability of MK-3475.

Secondary Outcome

Efficacy
-Disease control [CR, PR, or stable disease (SD)] assessed by independent central review
-Objective response and disease control assessed by the investigator

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.
9. 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.
10.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.

Exclude 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.
11.Active autoimmune disease that has required systemic treatment in past 2 years
12.History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
13.Active infection requiring systemic therapy.
14.History of human immunodeficiency virus (HIV) or Hepatitis B.
15.Active Hepatitis C virus infection.
16.Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
17.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.
18.Allogeneic hematopoietic stem cell/solid organ transplantation within the last 5 years.

Related Information

• Primary Sponsor: MSD K.K.
• Secondary ID(s): NCT04317066,JapicCTI-205263