NCT05404945
Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above
Active, Not Recruiting
PHASE2Ages 60+InterventionalTreatmentUniversity of VirginiaInvestigator-initiated
~24 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:PembrolizumabDoxorubicinVinblastineDacarbazineBrentuximab vedotin
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Remission Rate
Measured over 2 years
+1 more outcome measured
Conditions
Where it's being run
3 sites across 3 statesNew Jersey1
Pennsylvania1
Virginia1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants of any sex who are ≥60 years of age on day 1, cycle 1.
The participant must be willing and able to provide written informed consent for the trial and participate in all planned study procedures.
Histologically confirmed diagnosis of classical Hodgkin lymphoma
PET-avid, measurable disease (≥1.5cm bi-dimensional measurement)
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to
PS 2 may be allowed at the discretion of the treating investigator if impairment is considered to be primarily lymphoma-related. Evaluation of ECOG is to be performed within 10 days prior to the date of registration.
Participants who have received involved field radiation will be allowed. However, they will be excluded if any of the following are true:
Have adequate organ function as defined per protocol. Specimens must be collected within 10 days prior to registration (confirmation of eligibility).
Exclusion
Nodular lymphocyte-predominant Hodgkin lymphoma
Life expectancy \< 6 months for any reason excluding lymphoma
Has received prior therapy with an immune checkpoint inhibitor, against targets including but not limited to PD1, PDL1, PDL2, CTLA-4, OX40, or LAG 3 unless given with curative intent for reasons other than lymphoma AND the last dose was more than 3 years from registration. Any participant who received prior immune checkpoint inhibitor therapy will be excluded if they experienced any toxicity related to or possibly related to the immunotherapy that required discontinuation of drug.
Prior systemic therapy for cHL, with the exception of steroids
If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Presence of Grade ≥ 2 sensory and/or motor neuropathy
Prior solid organ or stem cell transplant.
Clinical suspicion or evidence of active involvement of lymphoma into the spinal cord, cerebral spinal fluid, or brain. External compression of the spinal cord or nerve roots is not considered involvement.
Is 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 treatment.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent \[excluding steroids needed for lymphoma related symptoms\]) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
Has known severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Interstitial lung disease or a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Any known history of pancreatitis as defined by Gandhi et al. 201432,36.
Has an active infection requiring oral or intravenous systemic therapy.
Has a known history of Human Immunodeficiency Virus (HIV).
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Prior exposure to hepatitis B is allowed as long as there are no HBsAg detected (ie positive Hepatitis B core antibody with negative HBsAg). Prior treatment with Hepatitis C is allowed if the screening HCV RNA by PCR is negative.
Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis).
Is currently taking a strong CYP3A4 modulator. Subjects taking strong CYP34A modulators that can safely stop these medications prior to treatment should complete a washout period of 4 weeks or 5 times the half-life of a particular drug, whichever is shorter.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is 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 trial treatment.
What this trial measures
- Complete Remission Rate2 years
Evaluate complete remission rate as defined by LYRIC criteria at end of induction in fit and unfit older participants with cHL following anthracycline-based chemotherapy.
- Incidence of grade 3-5 treatment-related AEs2 years
Assess tolerance and safety of a fitness-adapted pembrolizumab-based regimen in fit older participants with cHL based on incidence of grade 3-5 treatment-related AEs (CTCAE v5.0)