Molecular Tumor Board Recommendations for Cancer

(CATRINA Trial)

Overseen By Jacob R Dubien

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Untreated genetic alteration, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 36 months

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how advice from a specialized team, the Molecular Tumor Board, can guide cancer treatment choices. After conducting a detailed genetic study of the tumor, the team provides treatment suggestions to the doctors. The goal is to assess whether these recommendations help doctors make better treatment decisions and how they affect the patient's disease progression. Suitable participants have had genetic testing revealing specific tumor changes treatable with available drugs, such as Keytruda (an immunotherapy drug). As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to benefit from potentially effective treatment strategies.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Molecular Tumor Board recommendations are safe for cancer treatment decision-making?

Research shows that Molecular Tumor Boards (MTBs) customize cancer therapies based on genetic testing of tumors. However, direct evidence about the safety of treatments specifically recommended by MTBs remains limited. These treatments vary because they are tailored to each tumor's genetic details.

Many drugs or therapies suggested by MTBs might already be approved for other cancer types, indicating they have undergone safety testing for those uses. This generally suggests they might be safe, though side effects can vary depending on the treatment and the patient's condition.

In summary, while specific safety data for all MTB recommendations is lacking, the treatments often rely on existing therapies, offering some reassurance about their safety. Discussing any concerns with a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Molecular Tumor Board (MTB) recommendations because they offer a personalized approach to cancer treatment. Unlike standard treatments, which often follow a one-size-fits-all protocol, the MTB evaluates each patient's unique cancer profile to tailor recommendations specifically for them. This method aims to leverage the latest genetic insights and emerging therapies, potentially increasing the effectiveness and reducing unnecessary side effects compared to traditional treatments. By focusing on individualized care, the MTB could significantly improve outcomes for cancer patients, making it a promising avenue in cancer therapy advancement.

What evidence suggests that Molecular Tumor Board recommendations are effective for cancer treatment decisions?

Research shows that Molecular Tumor Boards (MTBs) help create personalized cancer treatments by analyzing the genetic details of tumors. Studies indicate that about 40% of cancers have genetic changes treatable with specific drugs. In this trial, the Molecular Tumor Board will evaluate subjects' cases and provide treatment recommendations. When patients received treatments suggested by MTBs, about 20.8% experienced positive outcomes, such as increased survival. This demonstrates that MTB recommendations can help develop effective treatment plans tailored to each patient's cancer. MTBs assist doctors in making better treatment decisions based on the unique genetic profile of a patient's cancer. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with cancer, who are fairly active (ECOG Performance Status of 0 to 2), have tumors that can be measured or evaluated, and have given verbal consent. Their tumor must have been genetically profiled with at least 100 genes and contain certain genetic alterations that could respond to treatment.

Inclusion Criteria

You need to agree by speaking that you want to be in the study before your case is reviewed.

I can join this study again if my cancer was retested after getting worse despite treatment.

I am able to get out of my bed or chair and move around.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Molecular Tumor Board Evaluation

Eligible subjects' cases are evaluated by the Molecular Tumor Board, and treatment recommendations are entered into the medical record

1 month

Treatment

Participants receive treatment based on Molecular Tumor Board recommendations, including tumor-targeted therapy or immunotherapy

Up to 36 months

Follow-up

Participants are monitored for disease progression and treatment impact, with surveys administered at 3 and 12 months

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Treatment recommendations made by Molecular Tumor Board

Trial Overview The study tests how recommendations from the Dartmouth Cancer Center's Molecular Tumor Board affect doctors' treatment decisions. After genetic profiling of tumors, these personalized recommendations are made and their impact is assessed through physician surveys.

How Is the Trial Designed?

Group I: Subjects evaluated by Molecular Tumor Board Experimental Treatment 1 Intervention

Subjects whose cases are evaluated by Molecular Tumor Board

Treatment recommendations made by Molecular Tumor Board is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Keytruda for:

• Melanoma
• Non Small Cell Lung Cancer
• Head and Neck Cancer
• Hodgkin's Lymphoma
• Stomach Cancer
• Cervical Cancer
• Breast Cancer

Approved in United States as Keytruda for:

• Melanoma
• Non Small Cell Lung Cancer
• Head and Neck Cancer
• Hodgkin's Lymphoma
• Stomach Cancer
• Cervical Cancer
• Breast Cancer
• Urothelial Carcinoma
• Endometrial Cancer

Approved in Japan as Keytruda for:

• Melanoma
• Non Small Cell Lung Cancer
• Head and Neck Cancer
• Hodgkin's Lymphoma
• Stomach Cancer
• Cervical Cancer
• Breast Cancer

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.

Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. Karim, S., Leighl, N.[2017]

Pembrolizumab (Keytruda) has been approved by the FDA for treating high-risk, non-muscle invasive bladder cancer (NMIBC) in patients who are unresponsive to BCG therapy and are either ineligible for or have opted not to undergo cystectomy.

This approval specifically targets patients with carcinoma in situ (CIS) with or without papillary tumors, highlighting its role as a treatment option for those with limited surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC. Wright, KM.[2021]

Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.

In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating unresectable or metastatic melanoma based on two clinical trials involving 1,374 patients, showing significant improvements in overall survival compared to ipilimumab, with hazard ratios indicating a reduced risk of death.

Patients receiving pembrolizumab also experienced significant improvements in progression-free survival, although some immune-mediated adverse reactions like hypothyroidism and pneumonitis were noted, highlighting the importance of monitoring for side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. Barone, A., Hazarika, M., Theoret, MR., et al.[2022]

Pembrolizumab (Keytruda) is approved for treating advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, specifically for patients whose disease has progressed after previous treatments.

This approval is significant for patients who are not candidates for curative surgery or radiation, providing a new therapeutic option for a challenging stage of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Approved Use for Keytruda. Aschenbrenner, DS.[2022]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.

The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/PO-24-00387

Real-World Outcomes of Molecular Tumor Board ... Recent findings suggest that around 40% of human malignancies bear genomic alterations suitable for treatment with molecularly targeted agents ( ...

2. nature.com nature.com/articles/s41698-025-00865-1

Systematic review and meta-analysis of molecular tumor ... Of these, 20.8% (2,532 patients) received MTB-recommended therapies, with 178 outcome measures reported, achieving a median overall survival (OS) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S095980492500214X

A decalogue of Molecular Tumor Board (MTB) ... A set of recommendations for Molecular Tumor Boards (MTBs) to address the lack of standardized guidelines in personalized cancer medicine.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12319421/

Real‐World Data From a Molecular Tumor Board‐Assisted ... Molecular tumor boards (MTBs) support the development of personalized treatment strategies for patients with various cancer types based on ...

5. jto.org jto.org/article/S1556-0864(25)00831-7/fulltext

Molecular Tumor Boards: A Consensus Statement From ... These MTB consensus recommendations are applicable across tumor types, despite being developed by lung cancer and molecular specialists and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11117617/

A Systematic Review and Meta-Analysis This systematic review evaluates the clinical outcomes and molecular predictors of response to pembrolizumab in patients with advanced and metastatic ...

7. aacrjournals.org aacrjournals.org/clincancerres/article/21/19/4286/125563/Phase-I-Study-of-Pembrolizumab-MK-3475-Anti-PD-1

Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 ... The results of this study support the continued development of pembrolizumab for various tumor types, as well as the recent approval of pembrolizumab 2 mg/kg ...