Phase 2 study of pembrolizumab and chemotherapy in participants with classical Hodgkin Lymphoma that has just been diagnosed
- Conditions
- Classical Hodgkin LymphomaMedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001244-95-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 140
1. Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV cHL. Stage I and II patients may be enrolled, but must have at least one NCCN unfavorable risk factor
2. Has measurable FDG-avid disease based on investigator assessment according to Lugano 2014 response criteria
3. Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy(including investigational agents) for the treatment of cHL before the first dose of study intervention
4. Is male or female, at least 18 years of age, at the time of signing the informed consent
5. Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows:
• Pembrolizumab: no contraception requirement
• Chemotherapy: 90 days
• Refrain from donating sperm
PLUS either:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent
OR
• Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:
- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant
• Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed
6. 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 WOCBP
OR
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period
The length of time required to continue contraception for each study intervention is as follows:
• Chemotherapy: 180 days
• Pembrolizumab: 120 days
The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 72 hours before the first dose of study intervention
- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
- Contraceptive use by women should be consistent with
1. Has confirmed nodular lymphocyte-predominant HL
2. Has an uncontrolled intercurrent cardiovascular illness including, but not limited to the following:
• Symptomatic congestive heart failure (ejection fraction lower than institutional LLN)
• Unstable angina pectoris
• Cardiac arrythmia
3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
4. Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
5. 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
6. 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 the first dose of study medication. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor
7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
8. Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis as assessed by investigator at the time of diagnosis
9. Has severe hypersensitivity (=Grade 3) to any of the study interventions or their excipients
10. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, 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) is not considered a form of systemic treatment and is allowed
11. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
12. Has a history or current evidence of pulmonary fibrosis
13. Has an active infection requiring systemic therapy
14. Has a known history of HIV infection. No HIV testing is required unless mandated by local health authority
15. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
16. 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
17. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
18. Has any contraindication to the use of any of the chemotherapeutic agents used in the study
19. Has not recovered adequately from surgery and/or any complications from the surgery
20. Has had an allogenic tissue/solid organ transplant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method