74 Participants Needed

Talquetamab/Teclistamab + PD-1 Inhibitor for Multiple Myeloma

(TRIMM-3 Trial)

Recruiting at 29 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop any prior antitumor therapy at least 21 days before starting the study treatment, with specific timeframes for certain therapies like proteasome inhibitors and immunomodulatory drugs. If you are on these types of medications, you will need to stop them before participating.

What safety data exists for PD-1 inhibitors in cancer treatment?

PD-1 inhibitors, used in various cancer treatments, generally have a manageable safety profile, making them suitable for outpatient use. However, they can cause side effects, including fever, increased liver enzyme levels, and rash, with some cases leading to severe reactions like pneumonitis (lung inflammation).12345

What makes the Talquetamab/Teclistamab + PD-1 Inhibitor treatment unique for multiple myeloma?

This treatment is unique because it combines Talquetamab and Teclistamab, which are antibodies targeting specific proteins on cancer cells, with a PD-1 inhibitor that helps the immune system attack cancer cells more effectively. This combination approach is novel for multiple myeloma, as it leverages both direct targeting of cancer cells and enhancement of the immune response.678910

What data supports the effectiveness of the drug combination Talquetamab/Teclistamab + PD-1 Inhibitor for Multiple Myeloma?

Talquetamab and Teclistamab have both been approved for treating relapsed or refractory multiple myeloma, showing promise in patients who have tried multiple other treatments. While PD-1 inhibitors alone have not been very effective, combining them with other drugs has shown potential benefits, suggesting that this combination could be more effective.1112131415

Who Is on the Research Team?

JR

Janssen Research and Development, LLC Clinical Trial

Principal Investigator

Janssen Research and Development LLC

Are You a Good Fit for This Trial?

This trial is for individuals with relapsed or refractory multiple myeloma who have measurable disease and are not candidates for established therapies. They must be in good physical condition (ECOG score of 0 or 1) and haven't received certain treatments recently, including PD-1 inhibitors, stem cell transplants, or live vaccines.

Inclusion Criteria

My condition has returned or didn't respond to treatment, and I can't use standard therapies.
I am fully active or restricted in physically strenuous activity but can do light work.
My cancer can be measured by blood or urine tests.
See 1 more

Exclusion Criteria

I have previously received PD-1 inhibitors or had a stem or organ transplant.
My multiple myeloma may be affecting my brain or spinal cord.
I haven't had cancer treatment in the last 3 weeks, including specific therapies in shorter time frames.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants will receive either talquetamab or teclistamab with a PD-1 inhibitor biweekly to identify safe dose levels

Up to 2 years 5 months

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

Up to 2 years 5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PD-1 Inhibitor
  • Talquetamab
  • Teclistamab
Trial Overview The study aims to determine safe doses when combining a PD-1 inhibitor with either talquetamab or teclistamab. It will also assess the safety and tolerability of these combinations in treating multiple myeloma.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment3 Interventions
Group II: Part 1: Dose EscalationExperimental Treatment3 Interventions

Talquetamab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Talquetamab for:
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Approved in European Union as Talquetamab for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Teclistamab, a bispecific antibody targeting CD3 and BCMA, has received conditional approval in the EU and full approval in the US for treating adult patients with relapsed or refractory multiple myeloma after multiple prior therapies.
The approvals are based on its efficacy in patients who have undergone at least three to four previous treatments, including specific types of therapies, highlighting its role as a treatment option for difficult-to-treat cases of multiple myeloma.
Teclistamab: First Approval.Kang, C.[2022]
The introduction of new therapies, including proteasome inhibitors, immunomodulators, and various immunotherapies like CAR T-cell treatments, has significantly improved the five-year survival rate for multiple myeloma to nearly 60%.
Despite these advancements, multiple myeloma remains incurable, as patients often become resistant to treatments and experience relapses, highlighting the need for ongoing research and development of new therapeutic strategies.
Immunotherapy of Multiple Myeloma: Current Status as Prologue to the Future.Abramson, HN.[2023]
Teclistamab-cqyv is an FDA and EMA-approved bispecific antibody that effectively targets multiple myeloma (MM) by engaging T cells to attack cancer cells, showing a 60% overall response rate in heavily pretreated relapsed/refractory patients.
This treatment is specifically designed for patients who have undergone at least three prior therapies and have shown disease progression, highlighting its role in advanced stages of MM where other treatments have failed.
Teclistamab-cqyv in multiple myeloma.Martino, EA., Bruzzese, A., Labanca, C., et al.[2023]

Citations

Teclistamab: First Approval. [2022]
Immunotherapy of Multiple Myeloma: Current Status as Prologue to the Future. [2023]
Teclistamab-cqyv in multiple myeloma. [2023]
Talquetamab: First Approval. [2023]
Promises and Pitfalls in the Use of PD-1/PD-L1 Inhibitors in Multiple Myeloma. [2019]
Efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy for triple-negative breast cancer: a systematic review and meta-analysis. [2022]
Pembrolizumab. [2022]
Antagonists of PD-1 and PD-L1 in Cancer Treatment. [2022]
Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Dabrafenib, trametinib and pembrolizumab or placebo in BRAF-mutant melanoma. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
An Anti-TIGIT Antibody with a PD-1 Inhibitor Shows Promise in Solid Tumors. [2022]
PD-L1 biomarker testing for non-small cell lung cancer: truth or fiction? [2022]
Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non-small-cell lung cancer. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Current Perspectives in Immunotherapy for Non-Small Cell Lung Cancer. [2020]
15.United Statespubmed.ncbi.nlm.nih.gov
Enhancing PD-1 Blockade in Solid Tumors. [2021]
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