ClinicalTrials.gg
RecruitingNCT06377540Updated Sep 29, 2026

MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma

A Phase 2 interventional study of Pembrolizumab and Autologous stem cell transplant in Autologous Stem Cell Transplant and Classic Hodgkin Lymphoma, sponsored by Masonic Cancer Center, University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Masonic Cancer Center, University of Minnesota · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Updated Sep 29, 2026Primary completion movedStudy completion movedGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 30 studies testing pembrolizumab in Hodgkin Disease — 13 open to participants now, 21 under way, 2 of them phase 3. pembrolizumab · Hodgkin Disease.

Planned enrollment
19th of 30
28 · median 34
Started
2024
with 4 others
Phase 2
22 of 30
11 open now
Primary completion
2027-09
later than 13 of 20 live
Registered
24th of 30
by date

Among the 30 studies testing pembrolizumab in Hodgkin Disease, this one is the 19th largest by planned enrollment, is one of 5 that started in 2024, is one of 22 in phase 2, reaches primary completion later than 13 of the 20 other live ones, and was the 24th registered.

Hodgkin Disease

1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.

Browse Hodgkin Disease studies →

Open to participants now

13 of the 30 studies testing pembrolizumab in Hodgkin Disease are open now, in 7 countries. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

About pembrolizumab

pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 136 Hodgkin Disease studies recruiting now, 73 (54%) set no upper age limit and 51 (38%) stop at 75 or younger; 46 take children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies testing pembrolizumab in Hodgkin Disease, or all of them as a file.
02

Study summary

This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.

03

Conditions studied

  • Autologous Stem Cell Transplant
  • Classic Hodgkin Lymphoma

Browse trials for

Keywords

  • BEAM
  • cHL
  • ASCT
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Eligible for stem cell transplant (ASCT) with BEAM conditioning regimen
  • greater than 70 or ≤ 1
  • Adequate organ function and blood counts within 14 days of study registration
  • Participants who are positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
  • Participants with a history of infection are eligible if HCV viral load is undetectable at screening.
  • -infected participants must have well-controlled HIV on ART

Exclusion criteria

Exclusion Criteria:

  • Patients with prior history of any grade 2 or higher reaction to inhibitors, necessitating permanent discontinuation of the PD-1 inhibitor or necessitating systemic .
  • Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring .
  • Has received a or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • Has received any chemotherapy within 3 weeks prior to the first dose of study intervention
  • Has known active CNS disease.
  • History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Exceptions: Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg/d) may enroll.
  • Has had an allogenic tissue/solid organ transplant.
  • Pregnant or breastfeeding as agents used in this study are Pregnancy Category D (positive evidence of risk). Females of must have a negative pregnancy test (serum or urine) within 14 days of study registration
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.

    Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.

    Drug: Pembrolizumab · Procedure: Autologous stem cell transplant · Drug: Carmustine · Drug: Etoposide · Drug: Cytarabine · Drug: Melphalan

Interventions

  • Patients will receive 200 mg Pembrolizumab on Day -28 and Day -6 by IV infusion. Pembrolizumab 200 mg IV will resume at day 30+ after ASCT every 3 weeks for 1 year.

    Also known as: Keytruda; MK-3475

  • ProcedureAutologous stem cell transplant

    On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.

    Also known as: ASCT

  • Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.

    Also known as: BCNU, BICNU

  • Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.

  • Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.

    Also known as: Ara-C

  • Melphalan will be given at dose of 140 mg/m2 intravenously on day -1 in a single 20 minute infusion; dose will be based on actual body weight but capped at 3.6 mg/kg as part of BEAM conditioning.

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    Number of participants with progression free survival at 1 year post transplant. Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.

    Time frame: Baseline to 1 year post-ASCT

Secondary outcomes

  1. Overall survival (OS)

    Time from date of study enrollment to date of death. Patients who do not die at the time of analysis will be censored at their last known date alive.

    Time frame: Baseline to 2 years post-ASCT

  2. Progression-free survival (PFS)

    Number of participants with progression free survival at 1 year post transplant. Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.

    Time frame: Baseline to 2 years post-ASCT

  3. Non-relapse mortality (NRM)

    Number of participants experiencing death without relapse.

    Time frame: Day 100 post-ASCT

  4. Overall Survival (OS)

    Time from date of study enrollment to date of death. Patients who do not die at the time of analysis will be censored at their last known date alive.

    Time frame: Baseline to 5 year post-ASCT

  5. Complete Radiologic Response Rate

    Participants experiencing complete radiologic response rate at day 28 post-ASCT.

    Time frame: Day 28

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Sep 2027, 32 months after the start.

Of 183 non-industry phase 2 interventional studies under Hodgkin Disease, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 115. This study's planned 32 months is below that.

Counting every sponsor, half of 206 studies reached it within 75 months; a quarter within 42 and three quarters within 111.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Sep 2026 → Sep 2027 and completion Sep 2027 → Sep 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2024
First posted
Apr 22, 2024
StartActual
Dec 4, 2024
Primary completionEst.
Sep 1, 2027was Sep 2026
CompletionEst.
Sep 1, 2028was Sep 2027
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Sep 1, 2026→Sep 1, 2027
Sep 29, 2026
Study completion
Sep 1, 2027→Sep 1, 2028
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Primary completion Sep 1, 2026→Sep 1, 2027
    Study completion Sep 1, 2027→Sep 1, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06377540
Responsible party
Sponsor
First posted
Apr 22, 2024
Start date
Dec 4, 2024
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Sanjal Desai
Contact
desai171@umn.edu
612-625-5469
Roberta Nicklow
Contact
nickl004@umn.edu

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Pembrolizumab

Start the discussion