Pembro-CORE pilot

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Cologne

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Jan 2024 → ongoing

Decision date (initial)

2023-06-05

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Merck Sharp and Dohme (MSD)

External identifiers

EU CT number

2022-501306-35-00

ClinicalTrials.gov

NCT04838652

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 1

1. Secondary objectives are to further explore efficacy, safety and feasibility of the new regimen.

Conditions and MedDRA coding

First relapse or primary refractory of classical Hodgkin lymphoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Histologically confirmed first relapse of cHL or primary refractory cHL
2. No previous treatment for r/r HL
3. Age: 18-65 years
4. Patient has given written informed consent to participate in the trial
5. Estimated life expectancy > 3 months
6. In women: negative pregnancy test
7. Presence of measurable disease - Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
8. 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
9. Patient is considered to be eligible for autologous stem cell transplantation by the investigator

Exclusion criteria 9

1. Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
2. Prior or concurrent disease that prevents treatment according to protocol
3. Malignant disease, other than cHL, within the last 5 years
4. Subjects with active, known or suspected autoimmune diease
5. Long-term ingestion of corticosteroids or antineoplastic drugs
6. ECOG performance status ≥ 2
7. Non-compliance
8. Female subject is pregnant or breastfeeding
9. Unsafe contraceptive methods

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Complete metabolic response (CMR) rate, defined as the proportion of patients with a Deauville score of 1-3 in the centrally reviewed restaging after treatment with 1 x pembrolizumab + 4 cycles of pembrolizumab and chemotherapy combined (4x P-ICE or 2x P-ICE + 2x P-DHAP).

Secondary endpoints 7

1. Complete metabolic response rate after 2 cycles of combination therapy
2. Remission status after end of treatment including pembrolizumab consolidation
3. Proportion of patients receiving HDCT and autologous stem-cell transplantation (ASCT)
4. Progression-free and overall survival after 1 and 2 years
5. Event-free survival after 1 and 2 years, defined as progression-free survival with the application of HDCT and ASCT counting as additional failure events
6. Adverse events
7. Patient-reported outcome (PRO-CTCAE, fatigue and quality of life)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Cologne

Sponsor organisation

University Of Cologne

Address

Albertus-Magnus-Platz 1

City

Cologne

Postcode

50923

Country

Germany

Scientific contact point

Organisation

University Of Cologne

Contact name

Peter Borchmann

Public contact point

Organisation

University Of Cologne

Contact name

Peter Borchmann

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 35 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications