Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)
NCT02603419
Last updated date
ABOUT THIS STUDY
This is a Phase 1b, open-label, multi-center study comprising a lead-in phase and an
expansion phase. The lead-in phase is a multiple-dose, randomized, parallel-arm,
pharmacokinetic and pharmacodynamic study of avelumab as a single agent in adult patients
with cHL. Patients enrolled in the lead-in phase of this study are required to have relapsed
following a prior autologous or allogeneic HSCT, or to be ineligible for HSCT. Based on the
preliminary TO, safety, and efficacy results from the lead-in phase, the expansion phase will
evaluate the anti-tumor activity and safety of single-agent avelumab utilizing an
intra-patient dose escalation paradigm based on two of the dosing regimens studied in the
lead-in phase in 40 cHL patients in whom an allogeneic HSCT has failed.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Hodgkins Lymphoma
Sex
Females and Males
Age
18 + years
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Hodgkins LymphomaAvelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)
NCT02603419
- Duarte, California
- Bologna, BO
- Rozzano, Milano
- Rosebank, Livingston
- Headington,
- Leeds,
- Leeds,
- Leicester,
- Leicester,
- London,
- London,
- Manchester,
- Plymouth,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | |||||
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Brief Title ICMJE | Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS) | ||||
Official Title ICMJE | A PHASE 1 PHARMACOKINETIC-PHARMACODYNAMIC STUDY OF AVELUMAB (MSB0010718C) IN PATIENTS WITH PREVIOUSLY TREATED ADVANCED STAGE CLASSICAL HODGKIN'S LYMPHOMA | ||||
Brief Summary | This is a Phase 1b, open-label, multi-center study comprising a lead-in phase and an expansion phase. The lead-in phase is a multiple-dose, randomized, parallel-arm, pharmacokinetic and pharmacodynamic study of avelumab as a single agent in adult patients with cHL. Patients enrolled in the lead-in phase of this study are required to have relapsed following a prior autologous or allogeneic HSCT, or to be ineligible for HSCT. Based on the preliminary TO, safety, and efficacy results from the lead-in phase, the expansion phase will evaluate the anti-tumor activity and safety of single-agent avelumab utilizing an intra-patient dose escalation paradigm based on two of the dosing regimens studied in the lead-in phase in 40 cHL patients in whom an allogeneic HSCT has failed. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Hodgkins Lymphoma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE | 34 | ||||
Original Estimated Enrollment ICMJE | 70 | ||||
Actual Study Completion Date ICMJE | April 11, 2019 | ||||
Actual Primary Completion Date | December 1, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | KEY INCLUSION CRITERIA
KEY EXCLUSION CRITERIA
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Italy, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02603419 | ||||
Other Study ID Numbers ICMJE | B9991007 2015-002636-41 ( EudraCT Number ) JAVELIN HODGKINS ( Other Identifier: Alias Study Number ) JAVELIN HODGKIN'S ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |