An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667).
- Conditions
- 10025319Hodgkin's Lymphoma
- Registration Number
- NL-OMON52677
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Type of participants and disease characteristics
- Must be a male or female between the age 3-25 years inclusive on the day of
signing informed consent/assent
- Newly diagnosed, pathologically confirmed classical Hodgkin Lymphoma: stage
IIEB, IIIEA, IIIEB, IIIB, IVA, IVB
- Measurable disease per investigator assessment
Contraception
- Male participants are eligible to participate if they agree to follow the
contracaption guidance clarified in the protocol. The lenght of time required
to continue contraception after the last dose for each study intervantion is
clarified in the protocol.
- A female participant is eligible if she is not pregnant, not breastfeeding
and not a woman of chilbearing potential OR agreeing to follow contraceptive
guidance according to protocol.
Informed consent
- The participant (or legally acceptable representative if applicable) provides
written informed consent/assent for the study
Additional Criteria
- Performance status:
- Lansky Play-Performance Scale >=50 for children up to 16 years of age
-Karnofsky score >=50 for participants >=16 years of age
- Adequate organ function
Medical Conditions
- Has undergone solid organ transplant at any time, or prior allogeneic
hematopoietic stem cell transplantation within the last 5 years.
- A WOCBP who has a positive urine pregnancy test within 24 hours before the
first dose of study treatment.
- Baseline left ventricular ejection fraction value <50% or shortening fraction
of <27%
Prior/Concomitant Therapy
- Has received prior therapy with anti-PD1/PD-L1/PD-L2 or with an agent
directed to another co-inhibitory T cell receptor or has previously
participated in a Merck pembro clinical study
- Received prior systemic anti-cancer therapy, including investigational agent
- Received a live or live-attenuated vaccine within 30 days before the first
dose of study intervention.
Prior/Concurrent Clinical Study Experience
- Has received an investigational agent or has used an investigational device
within 4 weeks prior to study intervention administration
Diagnostic assessments
- Has a diagnosis of lymphocyte-predominant HL
- Has a diagnosis of immunodeficiency or is expected to be receiving chronic
systemic steroid therapy or any other immunosuppressive therapy within 7 days
prior to the first dose of pembro.
- Has a known additional malignancy that is progressing or requires active
treatment within the past 3 years
- Has radiographically detectable central nervous system metastases and/or
carcinomatous meninginitis as assessed by local site investigator at the time
of diagnosis.
- Has severe hypersensitivity to any study therapies including any excipients.
- Has an active autoimmune disease that has required systemic treatment in past
2 years except replacement therapy.
- Has a history of (non-infectious) pneumonitis that required steroids or has
current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of Hepatitis B or known active Hepatitis C virus
infection.
- 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
cooperating with the requirements of the study.
- Participants who have not adequately recovered from major surgery or have
ongoing
surgical complications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Objective: To evaluate the objective response rate (ORR) by International<br /><br>Working Group (IWG) criteria as assessed by blinded independent central review<br /><br>(BICR) [Cheson, B. D., et al 2007] of pembrolizumab in combination with<br /><br>chemotherapy in slow early responders (SERs) by risk group (low, high)<br /><br>Objective response: Complete response (CR) or partial response (PR)</p><br>
- Secondary Outcome Measures
Name Time Method