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Trial record 1 of 1 for:    NCT03269136
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Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, As A Single Agent And In Combination With Either PF-06801591 Or Lenalidomide In Relapse/ Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03269136
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 16, 2017
First Posted Date  ICMJE August 31, 2017
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE November 29, 2017
Estimated Primary Completion Date December 12, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: 21 or 28 days ]
    Number of participants with DLTs, which are typically Grade 3 or higher adverse events
  • To evaluate anti-myeloma activity by objective response rate (ORR) in dose expansion [ Time Frame: From baseline and every 3-4 weeks through disease progression or study completion (approximately 2 years) ]
    Percentage of participants that have a best response of partial response or better using IMWG criteria
  • To evaluate anti-myeloma activity by duration of response (DOR) in dose expansion [ Time Frame: From start of response to end of response or study completion (approximately 2 years) ]
    Time from first assessment of partial response or better to last assessment of partial response or better by IMWG criteria
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
  • Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: 21 days ]
    First cycle DLTs during dose escalation in order to determine the maximum tolerated dose (MTD).
  • Dose Expansion: To assess clinical efficacy at RP2D. [ Time Frame: Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years). ]
    Overall response rate
  • Dose Expansion: To assess clinical efficacy at RP2D. [ Time Frame: Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years). ]
    Duration of response.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • To evaluate incidence of treatment emergent adverse events and laboratory abnormalities [ Time Frame: From baseline until end of study treatment or study completion (approximately 2 years) ]
    Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities
  • To evaluate anti-myeloma activity by objective response rate (ORR) in dose escalation [ Time Frame: From baseline and every 3-4 weeks through disease progression or study completion (approximately 2 years) ]
    Percentage of participants that have a best response of partial response or better using IMWG criteria
  • To evaluate anti-myeloma activity by time to event endpoints [ Time Frame: From baseline through time to event on study or study completion (approximately 2 years) ]
    Time from start date to date of first documentation of event (response or progression by IMWG criteria or death)
  • To evaluate anti-myeloma activity by duration of event endpoints [ Time Frame: From start of event endpoint to end of event endpoint or study completion (approximately 2 years) ]
    Time from first assessment of event endpoint (response or stable disease) to last assessment of (response or stable disease) by IMWG criteria
  • Impact of treatment on systemic soluble immune factors [ Time Frame: 9 months on treatment ]
    Pre and post dose quantification of soluble cytokines in serum.
  • Maximum plasma concentration (Cmax) of PF-06863135 [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (3 to 4 weeks) ]
    Peak concentration of PF-06863135 during first cycle
  • Trough serum concentrations of PF-06863135 and PF-06801591 [ Time Frame: From start of treatment until end of treatment or study completion (approximately 2 years) ]
    Trough serum concentrations of PF-06863135 and PF-06801591 at selected cycles
  • Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135 [ Time Frame: From start of treatment until end of treatment or study completion (approximately 2 years) ]
    AUC of PF-06863135 will be calculated at selected cycles
  • Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135 and PF-06801591 when combined with PF-06863135 [ Time Frame: From baseline and scheduled timepoints post dose through study completion (approximately 2 years) ]
    Number of participants with the presence of anti-PF-06863135 antibodies and PF-06801591 when combined with PF-06863135
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
  • To evaluate incidence of treatment emergent adverse events and laboratory abnormalities [ Time Frame: From baseline until 1 month after end of treatment ]
    Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities
  • To evaluate anti myeloma activity. [ Time Frame: Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years). ]
    Overall response rate
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: From baseline and scheduled timepoints post dose through study completion, on average 2 years ]
    Cmax will be calculated for PF-06863135.
  • Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) [ Time Frame: From baseline and scheduled timepoints post dose through study completion, on average 2 years ]
    Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose of PF-06863135 will be calculated.
  • Incidence of anti-drug antibodies [ Time Frame: From baseline and scheduled timepoints post dose through study completion, on average 2 years ]
    Number of participants with the presence of anti-PF-06863135 antibodies.
  • Impact of PF 06863135 on systemic soluble immune factors. [ Time Frame: From baseline and scheduled timepoints post dose through study completion, on average 2 years ]
    Pre and post dose quantification of soluble cytokines in serum.
  • To evaluate anti myeloma activity. [ Time Frame: Baseline, 1, 3, 9 and every 6 months thereafter until disease progression, unacceptable toxicity or end of study (average of 2 years). ]
    Time to event endpoints including duration of response.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study Of PF-06863135, A BCMA- CD3 Bispecific Ab, As A Single Agent And In Combination With Either PF-06801591 Or Lenalidomide In Relapse/ Refractory Multiple Myeloma
Official Title  ICMJE A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF PF-06863135, A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH EITHER PF-06801591 OR LENALIDOMIDE IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
Brief Summary To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed Description Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This two part study will assess the safety and tolerability of increasing dose levels of PF-06863135 in Part 1, and establish the recommended Phase 2 dose (RP2D) in Part 2.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: PF-06863135 monotherapy IV or SC
    PF-06863135 will be administered intravenously or subcutaneously.
  • Drug: PF-06863135 + PF-06801591
    PF-06863135 will be administered intravenously or subcutaneously.
  • Drug: PF-06863135 + lenalidomide
    PF-06863135 will be administered intravenously or subcutaneously.
Study Arms  ICMJE
  • Experimental: PF-06863135
    BCMA-CD3 bispecific antibody
    Intervention: Drug: PF-06863135 monotherapy IV or SC
  • Experimental: PF-06863135 + PF-06801591
    BCMA-CD3 bispecific antibody + anti-PD-1
    Intervention: Drug: PF-06863135 + PF-06801591
  • Experimental: PF-06863135 + lenalidomide
    BCMA-CD3 bispecific antibody + lenalidomide
    Intervention: Drug: PF-06863135 + lenalidomide
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2017)
80
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2017)
140
Estimated Study Completion Date  ICMJE December 12, 2022
Estimated Primary Completion Date December 12, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Relapsed/refractory multiple myeloma
  • Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
  • Performance Status of 0- 2 (unless due to bone pain)
  • Adequate bone marrow, hematological, kidney and liver function
  • Resolved acute effects of any prior therapy to baseline severity
  • Not pregnant

Exclusion Criteria:

  • Recent history of other malignancies
  • History of active autoimmune disorders
  • Any form of primary immunodeficiency
  • Active and clinically significant bacterial, fungal, or viral infection
  • Evidence of active mucosal or internal bleeding
  • History of severe immune-mediated adverse event with prior immunomodulatory treatment
  • Major surgery within 4 weeks of study treatment start
  • Radiation therapy within 2 weeks of study treatment start
  • History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
  • Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
  • Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
  • Requirement for systemic immune suppressive medication
  • Current requirement for chronic blood product support
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: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03269136
Other Study ID Numbers  ICMJE C1071001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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/data_requests.
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 June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP