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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05508867




Registration number
NCT05508867
Ethics application status
Date submitted
18/08/2022
Date registered
19/08/2022

Titles & IDs
Public title
A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)
Scientific title
A Phase 3 Randomized Clinical Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)
Secondary ID [1] 0 0
MK-4280A-008
Secondary ID [2] 0 0
4280A-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - favezelimab/pembrolizumab
Treatment: Drugs - bendamustine
Treatment: Drugs - gemcitabine

Experimental: Favezelimab/Pembrolizumab - Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.

Active comparator: Chemotherapy (Bendamustine or Gemcitabine) - Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.


Treatment: Other: favezelimab/pembrolizumab
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

Treatment: Drugs: bendamustine
IV infusion

Treatment: Drugs: gemcitabine
IV infusion
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 43 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 105 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by BICR
Timepoint [2] 0 0
Up to approximately 25 months
Secondary outcome [3] 0 0
Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR
Timepoint [3] 0 0
Up to approximately 43 months
Secondary outcome [4] 0 0
Number of Participants Who Experienced At Least One Adverse Event (AE)
Timepoint [4] 0 0
Up to approximately 27 months
Secondary outcome [5] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [5] 0 0
Up to approximately 24 months

Eligibility
Key inclusion criteria
* Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
* Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
* Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
* Submits an archival (=5 years) or newly obtained tumor tissue sample which has not been previously irradiated.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
* History of central nervous system (CNS) metastases or active CNS involvement.
* Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has an active infection requiring systemic treatment.
* History of hemophagocytic lymphohisticytosis.
* Has an active seizure disorder that is not well controlled.
* Has clinically significant (ie, active) cardiovascular disease.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
* Has not adequately recovered from major surgical procedure.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* History of human immunodeficiency virus (HIV).
* Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/06/2031
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Townsville Hospital ( Site 0006) - Townsville
Recruitment hospital [2] 0 0
Royal Adelaide Hospital ( Site 0005) - Adelaide
Recruitment hospital [3] 0 0
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0002) - St Albans
Recruitment hospital [4] 0 0
Royal Perth Hospital-Haematology ( Site 0004) - Perth
Recruitment postcode(s) [1] 0 0
4814 - Townsville
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3021 - St Albans
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Belgium
State/province [11] 0 0
Vlaams-Brabant
Country [12] 0 0
Belgium
State/province [12] 0 0
Namur
Country [13] 0 0
Brazil
State/province [13] 0 0
Sao Paulo
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Chile
State/province [16] 0 0
Region M. De Santiago
Country [17] 0 0
China
State/province [17] 0 0
Anhui
Country [18] 0 0
China
State/province [18] 0 0
Beijing
Country [19] 0 0
China
State/province [19] 0 0
Fujian
Country [20] 0 0
China
State/province [20] 0 0
Guangdong
Country [21] 0 0
China
State/province [21] 0 0
Henan
Country [22] 0 0
China
State/province [22] 0 0
Hubei
Country [23] 0 0
China
State/province [23] 0 0
Hunan
Country [24] 0 0
China
State/province [24] 0 0
Jilin
Country [25] 0 0
China
State/province [25] 0 0
Shanghai
Country [26] 0 0
China
State/province [26] 0 0
Sichuan
Country [27] 0 0
China
State/province [27] 0 0
Tianjin
Country [28] 0 0
China
State/province [28] 0 0
Zhejiang
Country [29] 0 0
Czechia
State/province [29] 0 0
Brno-mesto
Country [30] 0 0
Czechia
State/province [30] 0 0
Hradec Kralove
Country [31] 0 0
Czechia
State/province [31] 0 0
Praha 2
Country [32] 0 0
France
State/province [32] 0 0
Bretagne
Country [33] 0 0
France
State/province [33] 0 0
Haute-Garonne
Country [34] 0 0
France
State/province [34] 0 0
Haute-Vienne
Country [35] 0 0
France
State/province [35] 0 0
Rhone
Country [36] 0 0
France
State/province [36] 0 0
Seine-et-Marne
Country [37] 0 0
Germany
State/province [37] 0 0
Baden-Wurttemberg
Country [38] 0 0
Germany
State/province [38] 0 0
Nordrhein-Westfalen
Country [39] 0 0
Germany
State/province [39] 0 0
Sachsen
Country [40] 0 0
Israel
State/province [40] 0 0
Haifa
Country [41] 0 0
Israel
State/province [41] 0 0
Jerusalem
Country [42] 0 0
Israel
State/province [42] 0 0
Petah-Tikva
Country [43] 0 0
Israel
State/province [43] 0 0
Ramat Gan
Country [44] 0 0
Israel
State/province [44] 0 0
Tel Aviv
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Pusan-Kwangyokshi
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Poland
State/province [47] 0 0
Dolnoslaskie
Country [48] 0 0
Poland
State/province [48] 0 0
Malopolskie
Country [49] 0 0
Poland
State/province [49] 0 0
Mazowieckie
Country [50] 0 0
Poland
State/province [50] 0 0
Pomorskie
Country [51] 0 0
Poland
State/province [51] 0 0
Swietokrzyskie
Country [52] 0 0
Spain
State/province [52] 0 0
Cantabria
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Spain
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Cataluna
Country [54] 0 0
Spain
State/province [54] 0 0
La Coruna
Country [55] 0 0
Spain
State/province [55] 0 0
Las Palmas
Country [56] 0 0
Spain
State/province [56] 0 0
Alicante
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Malaga
Country [59] 0 0
Spain
State/province [59] 0 0
Salamanca
Country [60] 0 0
Sweden
State/province [60] 0 0
Skane Lan
Country [61] 0 0
Sweden
State/province [61] 0 0
Uppsala Lan
Country [62] 0 0
Switzerland
State/province [62] 0 0
Ticino
Country [63] 0 0
Turkey
State/province [63] 0 0
Istanbul
Country [64] 0 0
Turkey
State/province [64] 0 0
Ankara
Country [65] 0 0
Turkey
State/province [65] 0 0
Antalya
Country [66] 0 0
Turkey
State/province [66] 0 0
Izmir
Country [67] 0 0
Turkey
State/province [67] 0 0
Kocaeli
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Devon
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Glasgow City
Country [70] 0 0
United Kingdom
State/province [70] 0 0
London, City Of
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Oxfordshire
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Leeds
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Leicester
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05508867