Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/29/2018
Start Date:May 2016
End Date:August 2018

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A Phase 1b Dose Escalation Study to Assess the Safety of AFM13 in Combination With Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (KEYNOTE- 206)

The purpose of this study is to establish a dosing regimen for the combination therapy of
AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin
Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.


Main Inclusion Criteria:

1. Diagnosis of CD30+ classical Hodgkin lymphoma reconfirmed by histopathology. Note:
where reconfirmation is not possible, patients will still be eligible where they have
confirmation clearly documented in their medical records.

2. Relapsed or refractory disease after standard therapy including brentuximab vedotin
(Adcetris®).

3. Completion of, if applicable, radiotherapy, chemotherapy, antibodies and
immunoconjugates including brentuximab vedotin and/or another investigational drug
which could interact with this trial not less than 4 weeks (or 5 half-lives of the
drug, whichever occurs later) prior to first dose of study drug. Cessation of small
molecule tyrosine kinase inhibitors must be at least 7 days prior to first dose of
study drug.

4. Completion of, if applicable, an autologous stem cell transplantation (ASCT) at least
3 months prior to first dose of study drug.

5. Eastern Cooperative Oncology Group (ECOG) performance score (PS) <2.

Main Exclusion Criteria:

1. Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks of the first dose of treatment.

2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or if
the patient has previously participated in MK-3475 clinical trials.

3. Has received a live-virus vaccination within 30 days of planned treatment start. Note:
Seasonal flu vaccines that do not contain live virus are permitted.

4. Prior allogeneic stem cell transplantation (SCT) within the last 5 years.

5. Major surgery within 4 weeks prior to first dose of study drug.
We found this trial at
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Saint Louis, Missouri 63110
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1475 Northwest 12th Avenue
Coral Gables, Florida 33136
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Coral Gables, FL
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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199-203 Avinguda de la Gran Via de l'Hospitalet
L'Hospitalet de Llobregat, Barcelona 08908
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L'Hospitalet de Llobregat,
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Los Angeles, California 90095
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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Portland, OR
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Rochester, Minnesota 55905
Principal Investigator: Stephen M Ansell, M.D. Ph.D.
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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