JOURNAL ONKOLOGIE – STUDIE

TRIMM-3

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05338775

Studienbeginn:
Mai 2022

Letztes Update:
24.04.2024

Wirkstoff:
Talquetamab, Teclistamab, PD-1 Inhibitor

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

Janssen Research and Development, LLC Clinical Trial
Study Director
Janssen Research and Development LLC

Kontakt

Study Contact
Kontakt:
Phone: 844-434-4210
E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen

Studienlocations
(3 von 18)

Universitatsklinikum Carl Gustav Carus Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Hamburg Eppendorf
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps

Universitaetsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Universitatsklinikum Wurzburg
97080 Wuerzburg
(Bayern)
GermanyRekrutierend» Google-Maps

Colorado Blood Cancer Institute
80218 Denver
United StatesRekrutierend» Google-Maps

Icahn School of Medicine at Mount Sinai
10029 New York
United StatesRekrutierend» Google-Maps

Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps

Wake Forest Baptist Medical Center
27157 Winston-Salem
United StatesRekrutierend» Google-Maps

Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps

Vanderbilt - Ingram Cancer Center
37232 Nashville
United StatesRekrutierend» Google-Maps

CHU de Montpellier, Hopital Saint-Eloi
34295 Montpellier Cedex 5
FranceRekrutierend» Google-Maps

CHU de Nantes hotel Dieu
44093 Nantes Cedex 1
FranceRekrutierend» Google-Maps

CHU Poitiers - Hopital la Miletrie
86021 Poitiers
FranceRekrutierend» Google-Maps

Institut Universitaire du Cancer Toulouse Oncopole
31059 Toulouse Cedex 9
FranceRekrutierend» Google-Maps

Hosp. Univ. Germans Trias I Pujol
08916 Badalona
SpainRekrutierend» Google-Maps

Hosp. Univ. Fund. Jimenez Diaz
28040 Madrid
SpainRekrutierend» Google-Maps

Clinica Univ. de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps

Hosp. Clinico Univ. de Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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.

Studien-Arme

Experimental: Part 1: Dose Escalation
Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.
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.

Geprüfte Regime

Talquetamab:
Talquetamab will be administered as a subcutaneous (SC) injection.
Teclistamab:
Teclistamab will be administered as a SC injection.
PD-1 Inhibitor:
The PD-1 inhibitor will be administered as an intravenous injection.

Quelle: ClinicalTrials.gov

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