Authorised Therapeutic exploratory (Phase II) First relapse or primary refractory of classical Hodgkin lymphoma

Pembro-CORE pilot

EU CTIS ID: 2022-501306-35-00

What this study is testing

The aim of this trial is to develop an effective and well-tolerated regimen for treatment of r/r cHL by introducing the anti-PD-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ICE, DHAP). The primary objective of this prospective, multicenter phase II trial is to estimate efficacy of the novel combination therapy in the treatment of r/r cHL.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Histologically confirmed first relapse of cHL or primary refractory cHL
  • No previous treatment for r/r HL
  • Age: 18-65 years
  • Patient has given written informed consent to participate in the trial
  • Estimated life expectancy > 3 months
  • In women: negative pregnancy test

You likely can't join if

  • Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
  • Prior or concurrent disease that prevents treatment according to protocol
  • Malignant disease, other than cHL, within the last 5 years
  • Subjects with active, known or suspected autoimmune diease
  • Long-term ingestion of corticosteroids or antineoplastic drugs
  • ECOG performance status ≥ 2
See the full eligibility criteria
Who can join
  • Histologically confirmed first relapse of cHL or primary refractory cHL
  • No previous treatment for r/r HL
  • Age: 18-65 years
  • Patient has given written informed consent to participate in the trial
  • Estimated life expectancy > 3 months
  • In women: negative pregnancy test
  • Presence of measurable disease - Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of enrollment
  • Patient is considered to be eligible for autologous stem cell transplantation by the investigator
What rules you out
  • Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
  • Prior or concurrent disease that prevents treatment according to protocol
  • Malignant disease, other than cHL, within the last 5 years
  • Subjects with active, known or suspected autoimmune diease
  • Long-term ingestion of corticosteroids or antineoplastic drugs
  • ECOG performance status ≥ 2
  • Non-compliance
  • Female subject is pregnant or breastfeeding
  • Unsafe contraceptive methods

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.