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Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)

Last updated on March 27, 2020

FOR MORE INFORMATION
Study Location
City of Hope
Duarte, California, 91010 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hodgkins Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histological confirmation of classical Hodgkin's Lymphoma (cHL) with relapsed or
refractory disease who, for the lead-in phase, either have had a prior autologous or
allogeneic HSCT or are not eligible for HSCT, and , for the expansion phase, have had
a prior allogeneic HSCT. In the expansion phase there must be a documented CD3+ donor
chimerism of ≥20%.

- Patients must be off previous cHL therapy for at least 28 days prior to randomization
in the lead-in phase/first dose of study treatment in the expansion phase.

- At least 1 fluorodeoxyglucose (FDG) PET avid (Deauville 4/5) measurable lesion >1.5 cm
on PET-CT scan as defined by the Response Criteria for Malignant Lymphoma (for the
lead-in phase) and the Lugano Classification (for the expansion phase) that has not
previously been irradiated.

- Expansion phase: Required "de novo" or "archival" tumor biopsy, as well as required on
treatment biopsy

- Estern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients with prior allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) who
have had:

1. Lead-in phase: allo HSCT performed phase: allo-HSCT performed ?4 months prior to the first dose of study treatment.
NOTE: Patients who have had allo-HSCT performed >4 months prior to the first dose
of study treatment must have discontinued all immunosuppressive therapy, and must
have no clinical evidence of GVHD; or

2. Immunosuppressive treatment for acute or chronic GVHD within 3 months prior to
randomization for the lead-in phase or prior to the first dose of study treatment
for the expansion phase (with the exception of those patients who required 15
mg/day oral prednisone or equivalent). Patients who required 15 mg/day oral
prednisone or equivalent must have discontinued it within 7 days prior to first
dose of study treatment; or

3. Acute Grade 3 or Grade 4 GVHD at any time in the past (as defined by the modified
Seattle Glucksberg criteria (Consensus Conference on Acute GVHD Grading
Criteria); or

4. Prior chronic GVHD (as defined by the NIH Consensus Development Project) that
persisted for >6 months and required systemic immunosuppression (with the
exception of those patients who required 15 mg/day oral prednisone or
equivalent). Patients who required 15 mg/day oral prednisone or equivalent must
have discontinued it within 7 days prior to the first dose of study treatment; or

5. A donor lymphocyte infusion (DLI) within 3 months prior to randomization for the
lead-in phase or first dose of study treatment for the expansion phase.

- Prior therapy with an anti PD 1 or anti PD L1 mAb.

1. Lead-in Phase: May be enrolled if patient stopped prior anti PD1 or anti-PD-L1
therapy more than one year prior to randomization and had a documented prior
response.

2. Expansion Phase: Prior therapy with an anti-PD-1 or anti-PD-L1 agent following
allo-HSCT is prohibited unless the therapy was stopped more than one year prior
to the first dose of study treatment, and the patient had a documented prior
response. NOTE: Prior therapy with an anti-PD-1 or anti-PD-L1 agent prior to
allo-HSCT is permitted with no time limits and irrespective of a documented
response.

3. Patients with a history of ?Grade 3 anti-PD-1 or anti-PD-L1-related immune
toxicity are not eligible.

NCT02603419
Pfizer
Terminated
Avelumab In Patients With Previously Treated Advanced Stage Classical Hodgkin's Lymphoma (JAVELIN HODGKINS)

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Descriptive Information
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
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkins Lymphoma
Intervention  ICMJE
  • Drug: Avelumab
    Anti-PD-L1 antibody at X1 mg IV every 2 weeks to optimize dosing for expansion. Treatment with avelumab will continue until disease progression.
  • Drug: Avelumab
    Anti-PD-L1 antibody at X2 mg IV every 2 weeks to optimize dosing for expansion. Treatment with avelumab will continue until disease progression.
  • Drug: Avelumab
    Anti-PD-L1 antibody at X3 mg IV every 3 weeks to optimize dosing for expansion. Treatment with avelumab will continue until disease progression
  • Drug: Avelumab
    Anti-PD-L1 antibody at X3 mg IV every 2 weeks to optimize dosing for expansion. Treatment with avelumab will continue until disease progression
  • Drug: Avelumab
    Anti-PD-L1 antibody at X mg IV every 2 weeks. Treatment with avelumab will continue until disease progression
  • Drug: Avelumab
    Anti-PD-L1 antibody at X1 mg IV every 2 weeks which can be escalated to X4 mg every 2 weeks based on safety and efficacy. Treatment with avelumab will continue until disease progression.
Study Arms  ICMJE
  • Experimental: Lead-in phase-Cohort A
    X1 mg IV every 2 weeks
    Intervention: Drug: Avelumab
  • Experimental: Lead-in phase-Cohort B
    X2 mg IV every 2 weeks
    Intervention: Drug: Avelumab
  • Experimental: Lead-in phase-Cohort C
    X3 mg IV every 3 weeks
    Intervention: Drug: Avelumab
  • Experimental: Lead-in phase-Cohort D
    X4 mg IV every 2 weeks
    Intervention: Drug: Avelumab
  • Experimental: Lead-in phase-Cohort E
    X5 mg IV every 2 weeks
    Intervention: Drug: Avelumab
  • Experimental: Expansion phase
    X1 mg IV every 2 weeks followed by X1 or X4 mg every 2 weeks
    Intervention: Drug: Avelumab
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
 (submitted: March 12, 2020)
34
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
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

  • Histological confirmation of classical Hodgkin's Lymphoma (cHL) with relapsed or refractory disease who, for the lead-in phase, either have had a prior autologous or allogeneic HSCT or are not eligible for HSCT, and , for the expansion phase, have had a prior allogeneic HSCT. In the expansion phase there must be a documented CD3+ donor chimerism of ?20%.
  • Patients must be off previous cHL therapy for at least 28 days prior to randomization in the lead-in phase/first dose of study treatment in the expansion phase.
  • At least 1 fluorodeoxyglucose (FDG) PET avid (Deauville 4/5) measurable lesion >1.5 cm on PET-CT scan as defined by the Response Criteria for Malignant Lymphoma (for the lead-in phase) and the Lugano Classification (for the expansion phase) that has not previously been irradiated.
  • Expansion phase: Required "de novo" or "archival" tumor biopsy, as well as required on treatment biopsy
  • Estern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

KEY EXCLUSION CRITERIA

  • Patients with prior allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) who have had:

    1. Lead-in phase: allo HSCT performed <12 months prior to randomization. Expansion phase: allo-HSCT performed ?4 months prior to the first dose of study treatment. NOTE: Patients who have had allo-HSCT performed >4 months prior to the first dose of study treatment must have discontinued all immunosuppressive therapy, and must have no clinical evidence of GVHD; or
    2. Immunosuppressive treatment for acute or chronic GVHD within 3 months prior to randomization for the lead-in phase or prior to the first dose of study treatment for the expansion phase (with the exception of those patients who required 15 mg/day oral prednisone or equivalent). Patients who required 15 mg/day oral prednisone or equivalent must have discontinued it within 7 days prior to first dose of study treatment; or
    3. Acute Grade 3 or Grade 4 GVHD at any time in the past (as defined by the modified Seattle Glucksberg criteria (Consensus Conference on Acute GVHD Grading Criteria); or
    4. Prior chronic GVHD (as defined by the NIH Consensus Development Project) that persisted for >6 months and required systemic immunosuppression (with the exception of those patients who required 15 mg/day oral prednisone or equivalent). Patients who required 15 mg/day oral prednisone or equivalent must have discontinued it within 7 days prior to the first dose of study treatment; or
    5. A donor lymphocyte infusion (DLI) within 3 months prior to randomization for the lead-in phase or first dose of study treatment for the expansion phase.
  • Prior therapy with an anti PD 1 or anti PD L1 mAb.

    1. Lead-in Phase: May be enrolled if patient stopped prior anti PD1 or anti-PD-L1 therapy more than one year prior to randomization and had a documented prior response.
    2. Expansion Phase: Prior therapy with an anti-PD-1 or anti-PD-L1 agent following allo-HSCT is prohibited unless the therapy was stopped more than one year prior to the first dose of study treatment, and the patient had a documented prior response. NOTE: Prior therapy with an anti-PD-1 or anti-PD-L1 agent prior to allo-HSCT is permitted with no time limits and irrespective of a documented response.
    3. Patients with a history of ?Grade 3 anti-PD-1 or anti-PD-L1-related immune toxicity are not eligible.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2020

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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