Hodgkin's LymphomaPhase 2NCT04875195
A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68)
A Phase 2 study testing Pembrolizumab in people with Hodgkin's Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL), run by Merck Sharp & Dohme LLC at 27 sites in 11 countries.
Trial summary
The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab every six weeks (Q6W). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma, Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 27 sitesin 11 countries
- Study dates
- 7 Jun 2021to 13 Oct 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a histologically confirmed diagnosis of cHL or PMBCL, according to the World Health Organization (WHO) classification [Swerdlow, S. H., et al 2008].
- Has radiographically measurable cHL or PMBCL disease as per Lugano classification with at least 1 nodal lesion (which has not been previously radiated) that is >15 mm in long axis, regardless of the length of the short axis, and/or extranodal lesion of >10 mm in long and short axis.
- PMBCL-Specific Disease Characteristics:
- Have relapsed or refractory PMBCL and:
- Have relapsed after auto-stem cell transplant (SCT) or have failed to achieve a CR or PR within 60 days of auto-SCT. Participants may have received intervening therapy after auto-SCT for relapsed or refractory disease, in which case they must have relapsed after or be refractory to their last treatment.
- OR
Show all 24Show fewer
- For participants who are ineligible for auto-SCT, have received at least ≥2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. At least 1 of the prior lines of therapy must contain a rituximab-based regimen.
- Note: Participants should not need urgent cytoreductive therapy.
- Relapsed Disease: disease progression after achieving an overall response of PR or CR in response to the most recent therapy
- Refractory Disease: failure to achieve CR or PR to the most recent therapy.
- cHL-Specific Disease Characteristics:
- Have relapsed or refractory cHL and:
- Have relapsed during their last cHL regimen after receiving at least 2 cycles of therapy or within 12 months after completing the last regimen for cHL.
- OR
- Have received at least ≥1 line of prior multiagent therapy with/without brentuximab vedotin (excluding radiation) or auto-SCT for cHL and have failed to respond to or relapsed after their last line of treatment.
- Relapsed Disease: disease progression after achieving an overall response of PR or CR to the most recent therapy.
- Refractory Disease: failure to achieve CR or PR to the most recent therapy.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of child bearing potential (WOCBP). OR
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), for at least 120 days after the last dose of study intervention.
- Submit an evaluable core lymph node biopsy for biomarker analysis from an archival (>60 days) or newly obtained (within 30 days) core or incisional biopsy at Screening which was not previously irradiated. Note: If no archival tissue is available, 2 new fresh core needle samples are required.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy >3 months.
- Adequate organ function.
Who cannot join
- Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic SCT within the last 5 years
- Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
- Has pericardial effusion or clinically significant pleural effusion
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers
- Is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) <3 days prior to the first dose of study intervention. Note: Participants who receive daily steroid replacement therapy are an exception
- Has received prior monoclonal antibody within 4 weeks prior to first dose of study intervention or has not recovered (i.e., ≤Grade 1 or at baseline) from adverse event (AEs) due to agents administered more than 4 weeks earlier
Show all 20Show fewer
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
- Has received prior chimeric antigen receptor T-cell (CAR-T) therapy
- Has received prior systemic anticancer therapy, or radiotherapy, including investigational agents within 4 weeks prior to the first dose of study intervention. Note: If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
- Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities, and not require corticosteroids
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
- Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
- Has a known history of Hepatitis B (defined as hepatitis B surface antigen (HBsAg) reactive) or known active Hepatitis C virus infection
Trial locations and contacts
27 sites in 11 countries.
27 sites in 11 countries
United States3 sites
Anne Arundel Medical Center-Anne Arundel Oncology and Hematology ( Site 0125)
Annapolis, Maryland, 21401
Tulane Medical Center ( Site 0110)
New Orleans, Louisiana, 70112
Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site
Torrance, California, 90502
Czechia3 sites
Fakultni nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0302)
Brno, Brno-mesto, 625 00
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0304)
Hradec Králové, 500 05
Fakultni nemocnice Kralovske Vinohrady-Interni hematologicka klinika ( Site 0303)
Prague, Praha 10, 100 34
Italy3 sites
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0503)
Naples, 80131
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0507)
Palermo, Sicily, 90146
Fondazione IRCCS Policlinico San Matteo ( Site 0509)
Pavia, Lombardy, 27100
Poland3 sites
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0063)
Gdansk, Pomeranian Voivodeship, 80-952
Pratia MCM Krakow ( Site 0064)
Krakow, Lesser Poland Voivodeship, 30-510
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-Oddzial Hematologii i Transplantacji S
Poznan, Greater Poland Voivodeship, 61-848
Russia3 sites
The National Medico-Surgical Center N.I. Pirogov ( Site 0801)
Moscow, Moscow, 105203
Moscow City Clinical Hospital S.P. Botkin ( Site 0803)
Moscow, Moscow, 125284
Almazov National Medical Research Centre ( Site 0807)
Saint Petersburg, Sankt-Peterburg, 197341
South Africa3 sites
Groote Schuur Hospital ( Site 0906)
Cape Town, Western Cape, 7925
Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 0902)
Centurion, Gauteng, 0044
Wits Clinical Research ( Site 0904)
Johannesburg, Gauteng, 1864
Brazil2 sites
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1701)
Barretos, São Paulo, 14784-400
Hospital Erasto Gaertner ( Site 1703)
Curitiba, Paraná, 81520-060
France2 sites
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 0401)
Dijon, Cote-d Or, 21000
Gustave Roussy ( Site 0402)
Villejuif, Île-de-France Region, 94800
Turkey (Türkiye)2 sites
Ankara University Department of Hematology, Clinical Research Unit ( Site 1101)
Ankara, 06100
Ege University Medicine of Faculty ( Site 1105)
Bornova, İzmir, 35100
Ukraine2 sites
CNPE Regional Center of Oncology ( Site 1305)
Kharkiv, Kharkiv Oblast, 61070
National Cancer Institute ( Site 1303)
Kyiv, Kyivska Oblast, 03022
About this study
Official title: A Phase 2 Study of Pembrolizumab (MK-3475) Every 6 Weeks (Q6W) in Participants With Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab every six weeks (Q6W).
- Being tested
- Pembrolizumab
- Keywords
- PD1, PD-1, PDL1, PD-L1
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called MK-3475, SCH 900475, KEYTRUDA®
Pembrolizumab, 400 mg, Q6W, intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Pembrolizumab (MK-3475), 400 mg, Q6W, intravenous (IV) infusion, Day 1 then Q6W up to 18 doses. Receives: Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator
ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose- positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). The percentage of participants treated with pembrolizumab Q6W, by cohort, rrcHL and rrPMBCL, who experienced CR or PR as assessed by investigator is presented.
Measured: Up to approximately 30 months
Secondary outcomes (12)
ORR Per Lugano Classification as Assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). The percentage of participants treated with pembrolizumab Q6W, by cohort, rrcHL and rrPMBCL, who experienced CR or PR as assessed by BICR is presented.
Measured: Up to approximately 30 months
Duration of Response (DOR) Per Lugano Classification as Assessed by Investigator
For participants who demonstrate a CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Participants were evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR as assessed by investigator is presented among participants who demonstrated CR or PR.
Measured: Up to approximately 51 months
DOR Per Lugano Classification as Assessed by BICR
For participants who demonstrate a CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Participants were evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR as assessed by BICR is presented among participants who demonstrated CR or PR.
Measured: Up to approximately 51 months
Area Under the Curve (AUC) Early Cycle of Pembrolizumab
AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time. Blood samples were collected to determine the AUC of pembrolizumab during Cycle 1 (early cycle). A cycle was 6 weeks.
Measured: Predose on Day 1 and Day 42 of Cycle 1 (cycle length=6 weeks)
Area Under the Curve (AUC) Steady State of Pembrolizumab
AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time. Blood samples were collected to determine the AUC of pembrolizumab during Cycle 4 (steady state). A cycle was 6 weeks.
Measured: Predose on Day 1 and Day 42 of Cycle 4 (cycle length=6 weeks)
Maximum Serum Concentration (Cmax) Early Cycle of Pembrolizumab
Cmax is defined as the maximum serum drug concentration. Blood samples were collected to determine the Cmax of pembrolizumab during Cycle 1 (early cycle).
Measured: Predose on Day 1 of Cycle 1 and end of infusion on Day 1 of Cycle 1 (cycle length = 6 weeks)
Maximum Serum Concentration (Cmax) Steady State of Pembrolizumab
Cmax is defined as the maximum serum drug concentration. Blood samples were collected to determine the Cmax of pembrolizumab during Cycle 4 (steady state).
Measured: Predose on Day 1 of Cycle 4, and end of infusion on Day 1 of Cycle 4 (cycle length = 6 weeks)
Trough Serum Concentration (Ctrough) Early Cycle of Pembrolizumab
Ctrough is defined as the lowest serum drug concentration at the end of dosing interval. Blood samples were collected to determine the Ctrough of pembrolizumab during Cycle 1 (early cycle).
Measured: Predose on Day 1 of Cycle 1 and Day 42 of Cycle 1 (cycle length = 6 weeks)
Trough Serum Concentration (Ctrough) Steady State of Pembrolizumab
Ctrough is defined as the lowest serum drug concentration at the end of dosing interval. Blood samples were collected to determine the Ctrough of pembrolizumab during Cycle 4 (steady state).
Measured: Predose on Day 1 of Cycle 1 and Day 42 of Cycle 4 (cycle length = 6 weeks)
Antidrug Antibody Levels (ADA) for Pembrolizumab
Blood samples were collected and assayed for anti-pembrolizumab antibodies presence using a validated electrochemiluminescence immunoassay. Negative ADA refers to all pre-treatment and postdose samples negative in the assay for antibodies against pembrolizumab and the concentration of pembrolizumab in the last postdose sample below the drug tolerance level. Treatment emergent positive was defined as pre-treatment sample negative and at least one postdose sample positive in the assay or pre-treatment and postdose sample positive with an increase in titer (≥2 fold of baseline). Non-treatment emergent positive was defined as pre-treatment sample positive and postdose sample negative or pre-treatment and postdose sample positive with a postdose titer <2 fold of baseline. Neutralizing positive was defined as at least 1 of the ADA positive samples test positive in the neutralizing assay.
Measured: Predose 0-4 hours on Cycle1 Day1, Cycle2 Day1, Cycle4 Day1, Cycle5 Day1, Cycle7 Day1, Cycle9 Day1, Cycle13 Day1, Cycle17 Day1 and end of infusion on Cycle1 Day1, Cycle4 Day1 and anytime on Cycle1 Day22 and Cycle4 Day22 (cycle length = 6 weeks)
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to approximately 51 months
Number of Participants Who Discontinued Study Treatment Due to AE
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to approximately 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start7 Jun 2021
- Primary completion14 Dec 2023
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875195
- Sponsor's protocol ID
- 3475-B68
- Other IDs
- MK-3475-B68, 2024-510979-38-00, U1111-1302-8634, 2020-005609-20
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2021
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Pembrolizumab (MK-3475) Every 6 Weeks (Q6W) in Participants With Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
- ClinicalTrials.gov ID
- NCT04875195
- Acronym / sponsor ID
- 3475-B68
- Keywords
- PD1, PD-1, PDL1, PD-L1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab every six weeks (Q6W).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: PembrolizumabPembrolizumab (MK-3475), 400 mg, Q6W, intravenous (IV) infusion, Day 1 then Q6W up to 18 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Have a histologically confirmed diagnosis of cHL or PMBCL, according to the World Health Organization (WHO) classification [Swerdlow, S. H., et al 2008].
- Has radiographically measurable cHL or PMBCL disease as per Lugano classification with at least 1 nodal lesion (which has not been previously radiated) that is >15 mm in long axis, regardless of the length of the short axis, and/or extranodal lesion of >10 mm in long and short axis.
- Have relapsed or refractory PMBCL and:
- Have relapsed after auto-stem cell transplant (SCT) or have failed to achieve a CR or PR within 60 days of auto-SCT. Participants may have received intervening therapy after auto-SCT for relapsed or refractory disease, in which case they must have relapsed after or be refractory to their last treatment.
- OR
Key exclusion criteria (20 listed)
- Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic SCT within the last 5 years
- Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
- Has pericardial effusion or clinically significant pleural effusion
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers
- Is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) <3 days prior to the first dose of study intervention. Note: Participants who receive daily steroid replacement therapy are an exception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: MK-3475, SCH 900475, KEYTRUDA®Pembrolizumab, 400 mg, Q6W, intravenous (IV) infusion. | Biological | Arm 1 |
Primary outcome
Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator
Time frame: Up to approximately 30 months
ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose- positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). The percentage of participants treated with pembrolizumab Q6W, by cohort, rrcHL and rrPMBCL, who experienced CR or PR as assessed by investigator is presented.
12 secondary outcomes
ORR Per Lugano Classification as Assessed by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 30 months
Duration of Response (DOR) Per Lugano Classification as Assessed by Investigator
Time frame: Up to approximately 51 months
DOR Per Lugano Classification as Assessed by BICR
Time frame: Up to approximately 51 months
Area Under the Curve (AUC) Early Cycle of Pembrolizumab
Time frame: Predose on Day 1 and Day 42 of Cycle 1 (cycle length=6 weeks)
Area Under the Curve (AUC) Steady State of Pembrolizumab
Time frame: Predose on Day 1 and Day 42 of Cycle 4 (cycle length=6 weeks)
Maximum Serum Concentration (Cmax) Early Cycle of Pembrolizumab
Time frame: Predose on Day 1 of Cycle 1 and end of infusion on Day 1 of Cycle 1 (cycle length = 6 weeks)
Maximum Serum Concentration (Cmax) Steady State of Pembrolizumab
Time frame: Predose on Day 1 of Cycle 4, and end of infusion on Day 1 of Cycle 4 (cycle length = 6 weeks)
Trough Serum Concentration (Ctrough) Early Cycle of Pembrolizumab
Time frame: Predose on Day 1 of Cycle 1 and Day 42 of Cycle 1 (cycle length = 6 weeks)
Trough Serum Concentration (Ctrough) Steady State of Pembrolizumab
Time frame: Predose on Day 1 of Cycle 1 and Day 42 of Cycle 4 (cycle length = 6 weeks)
Antidrug Antibody Levels (ADA) for Pembrolizumab
Time frame: Predose 0-4 hours on Cycle1 Day1, Cycle2 Day1, Cycle4 Day1, Cycle5 Day1, Cycle7 Day1, Cycle9 Day1, Cycle13 Day1, Cycle17 Day1 and end of infusion on Cycle1 Day1, Cycle4 Day1 and anytime on Cycle1 Day22 and Cycle4 Day22 (cycle length = 6 weeks)
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 51 months
Number of Participants Who Discontinued Study Treatment Due to AE
Time frame: Up to approximately 25 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
27 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Hodgkin's Lymphoma and Primary Mediastinal Large B-cell Lymphoma (PMBCL), run by Merck Sharp & Dohme LLC at 27 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Czechia, Italy, Poland, Russia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator (time frame: Up to approximately 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.