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A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma (TRIMM-3)

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ClinicalTrials.gov Identifier: NCT05338775
Recruitment Status : Recruiting
First Posted : April 21, 2022
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.

Condition or disease Intervention/treatment Phase
Relapsed/ Refractory Multiple Myeloma Drug: Talquetamab Drug: Teclistamab Drug: PD-1 Inhibitor Phase 1

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Detailed Description:
Multiple myeloma is a malignant plasma cell disorder that accounts for approximately 10 percent (%) of all hematologic cancers, making it the second most common hematologic malignancy. The overall rationale of this study is that talquetamab or teclistamab in combination with a PD-1 inhibitor may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study will evaluate the clinical hypothesis that talquetamab or teclistamab can be safely administered at the selected dose when combined with a PD-1 inhibitor. The study will consist of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up. End of study is defined as last study assessment for last participant in study. Total duration of study is up to 2 years 5 months. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination With Checkpoint Inhibition for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : May 25, 2022
Estimated Primary Completion Date : September 21, 2024
Estimated Study Completion Date : October 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Escalation
Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.
 Drug: Talquetamab
Talquetamab will be administered as a subcutaneous (SC) injection.

Drug: Teclistamab
Teclistamab will be administered as a SC injection.

Drug: PD-1 Inhibitor
The PD-1 inhibitor will be administered as an intravenous injection.
Experimental: Part 2: Dose Expansion
Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.
 Drug: Talquetamab
Talquetamab will be administered as a subcutaneous (SC) injection.

Drug: Teclistamab
Teclistamab will be administered as a SC injection.

Drug: PD-1 Inhibitor
The PD-1 inhibitor will be administered as an intravenous injection.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 2 years 5 months ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  2. Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to 2 years 5 months ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

  3. Number of Participants with Abnormalities in Clinical Laboratory Assessments [ Time Frame: Up to 2 years 5 months ]
    Number of participants with abnormalities in clinical laboratory assessments (serum chemistry and hematology) will be reported.

  4. Number of Participants with Dose-Limiting Toxicity (DLTs) [ Time Frame: Up to 2 years 5 months ]
    The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 2 years 5 months ]
    ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria.

  2. Very Good Partial Response (VGPR) or Better Response Rate [ Time Frame: Up to 2 years 5 months ]
    VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.

  3. Complete Response (CR) or Better Response Rate [ Time Frame: Up to 2 years 5 months ]
    CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.

  4. Stringent Complete Response (sCR) Rate [ Time Frame: Up to 2 years 5 months ]
    sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.

  5. Duration of Response [ Time Frame: Up to 2 years 5 months ]
    Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 criteria or death due to any cause, whichever occurs first.

  6. Time to Response [ Time Frame: Up to 2 years 5 months ]
    Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.

  7. Serum Concentrations of Talquetamab [ Time Frame: Up to 2 years 5 months ]
    Serum samples will be analyzed to determine concentrations of Talquetamab using validated, specific, and sensitive immunoassay methods.

  8. Serum Concentrations of Teclistamab [ Time Frame: Up to 2 years 5 months ]
    Serum samples will be analyzed to determine concentrations of Teclistamab using validated, specific, and sensitive immunoassay methods.

  9. Serum Concentrations of PD-1 Inhibitor [ Time Frame: Up to 2 years 5 months ]
    Serum samples will be analyzed to determine concentrations of PD-1 inhibitor using validated, specific, and sensitive immunoassay methods.

  10. Number of Participants with Anti-Talquetamab Antibodies [ Time Frame: Up to 2 years 5 months ]
    Number of participants with anti-talquetamab antibodies will be reported.

  11. Number of Participants with Anti-Teclistamab Antibodies [ Time Frame: Up to 2 years 5 months ]
    Number of participants with anti-teclistamab antibodies will be reported.

  12. Number of Participants with Anti-PD-1 Inhibitor Antibodies [ Time Frame: Up to 2 years 5 months ]
    Number of participants with anti-PD-1 inhibitor antibodies will be reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit
  • Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level >= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

  • Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months)
  • Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant
  • Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
  • Active Central Nervous System (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia [any grade] or peripheral neuropathy to Grade <= 2)
  • Received a cumulative dose of corticosteroids equivalent to >= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05338775


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research and Development, LLC Clinical Trial Janssen Research and Development LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05338775    
Other Study ID Numbers: CR109168
2021-005073-22 ( EudraCT Number )
64407564MMY1005 ( Other Identifier: Janssen Research and Development, LLC )
2022-502681-24-00 ( Registry Identifier: EUCT number )
First Posted: April 21, 2022    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
 Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents