Clinical Trial Match-List Intervention for Cancer Research Access

(DISRUPT Trial)

Recruiting at 4 trial locations

Overseen By Radhi Yagnik

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Unable to consent, language barrier, others

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

Compensation: Varies

Number of Visits: Unknown

644 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving access to cancer research for individuals in diverse and underserved communities. It aims to match patients with invasive breast, lung, or liver cancer to suitable clinical trials, assisting them in making informed treatment decisions. The trial involves both patients who need to make treatment choices and their doctors, aiming to increase awareness and participation in cancer research. Eligible participants include those with invasive breast, lung, or liver cancer who speak English or Spanish and need to decide on treatment soon. As an unphased trial, this study offers a unique opportunity to contribute to cancer research and potentially benefit from cutting-edge treatment options.

Will I have to stop taking my current medications?

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

What prior data suggests that this match-list intervention is safe for cancer research access?

Research has shown that the clinical trial match-list intervention does not involve traditional drug treatments, so typical safety data like side effects or adverse events do not apply. Instead, this intervention aims to improve access to clinical trials for cancer patients by connecting patients and doctors with suitable trials based on important clinical details. As it is not a medical treatment, there is no risk of physical side effects. The main goal is to simplify the process for patients to find and join trials, ensuring a safe experience for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance access to clinical trials for cancer patients through a match-list intervention. Unlike traditional treatment options that involve chemotherapy, surgery, or radiation, this approach focuses on improving how patients and oncologists connect with relevant clinical trials. By streamlining the process of finding suitable trials for specific cases of invasive breast, prostate, or liver cancer, this intervention could potentially offer patients better-aligned treatment options and accelerate the discovery of new therapies. The hope is that this will lead to more personalized and effective cancer care, ultimately improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that services matching patients to clinical trials are effective. Automated tools for cancer screening and matching accurately identify suitable trials for patients. In this trial, participants will engage in a match-list intervention designed to improve access to clinical trials. These services help more people join trials by matching them based on specific health conditions. Studies have found that these tools can increase patient participation in cancer trials, offering more people access to potential new treatments. This approach aims to provide a wider range of patients, especially those in underserved communities, with opportunities to participate in clinical research. ^{6 7 8 9 10}

Who Is on the Research Team?

Nina Bickell

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults over 21 with invasive breast, prostate, or liver cancer who are facing a treatment decision. Participants must be able to consent and communicate in English or Spanish. Oncologists and related specialists caring for these patients can also join if they agree.

Inclusion Criteria

For provider recruitment, oncologists, and advanced practitioners caring for patients with breast, prostate, liver cancer including medical, surgical, radiation oncologists, interventional radiologists, urologists & hepatologists.

Patients of doctors who have consented to participate

I am over 21 and have breast, prostate, or liver cancer needing treatment decisions.

Exclusion Criteria

You are not in urgent need of medical treatment.

I do not have invasive breast, prostate, or liver cancer.

I cannot understand English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of interventions aimed at improving diversity and inclusion in clinical trials through community engagement, electronic matching of patients to trials, and training in diversity and social determinants of health.

6 months

Follow-up

Participants are monitored for changes in clinical trial accrual rates and feedback from physicians and patients post-intervention.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Clinical trial match-list
• Match-list intervention

Trial Overview DISRUPT aims to improve diversity in clinical trials (CTs) by creating new community norms around cancer care, matching patients with CTs electronically at decision points, and integrating training on diversity into scientific research.

How Is the Trial Designed?

Group I: Patient Participants Active Control 1 Intervention

Patients with invasive breast, prostate or liver cancer, who face a treatment decision

Group II: Physician Participants Active Control 1 Intervention

Oncologists, and advanced practitioners caring for patients with breast, prostate, liver cancer including medical, surgical, radiation oncologists, interventional radiologists, urologists \& hepatologists

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study involving 34 patients with BRCA1 or BRCA2 mutated metastatic breast cancer, the combination of olaparib and durvalumab demonstrated promising antitumor activity, with 80% of patients showing disease control at 12 weeks.

The treatment was generally safe, with 32% of patients experiencing grade 3 or worse adverse events, but no treatment-related deaths were reported, indicating a manageable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study. Domchek, SM., Postel-Vinay, S., Im, SA., et al.[2021]

Olaparib (Lynparza) is approved for treating adult patients with high-risk early breast cancer that has a germline BRCA mutation, following chemotherapy treatment.

This approval highlights Olaparib's role as an adjuvant therapy, which means it is used after initial treatments to help prevent cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Adjuvant Treatment for High-Risk Early Breast Cancer. Aschenbrenner, DS.[2022]

Olaparib, a PARP inhibitor, showed a 36% objective response rate in women with relapsed ovarian cancer and a germline BRCA1/2 mutation, even after they had undergone multiple lines of chemotherapy, indicating its efficacy in this challenging patient population.

The median duration of response to olaparib was 7.4 months, and the safety profile was consistent across patients who had received three or more lines of prior chemotherapy, with similar rates of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Matulonis, UA., Penson, RT., Domchek, SM., et al.[2022]

The combination of olaparib and durvalumab (O+D) showed a progression-free survival rate of 35% at 6 months in patients with advanced solid tumors, including rare cancers with homologous recombination repair (HRR) defects, indicating its efficacy in this challenging patient population.

O+D was found to be safe, with only 6% of patients experiencing serious adverse events, and it produced durable objective tumor responses in several rare cancer types, suggesting it could be a promising treatment option without new toxicity concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A signal-seeking Phase 2 study of olaparib and durvalumab in advanced solid cancers with homologous recombination repair gene alterations. Thavaneswaran, S., Kansara, M., Lin, F., et al.[2023]

In the phase III OlympiAD trial, olaparib significantly improved progression-free survival (PFS) in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer, with a median PFS of 8.0 months compared to 3.8 months for chemotherapy, indicating a strong efficacy of olaparib.

Subgroup analyses showed consistent benefits of olaparib across various patient characteristics, including hormone receptor status and prior chemotherapy, with higher objective response rates and improved quality of life compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib efficacy in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer: Subgroup analyses from the phase III OlympiAD trial. Senkus, E., Delaloge, S., Domchek, SM., et al.[2023]

Olaparib is particularly effective for patients with BRCA-mutated ovarian cancer, but it also benefits a subset of patients with BRCA wild-type tumors that have loss-of-function mutations in DNA repair genes, showing similar treatment outcomes.

The study suggests that patients with specific HRR gene mutations, even without BRCA mutations, can be identified as a group that may respond well to olaparib, indicating a potential for broader use of this treatment in ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Candidate biomarkers of PARP inhibitor sensitivity in ovarian cancer beyond the BRCA genes. Hodgson, DR., Dougherty, BA., Lai, Z., et al.[2020]

Olaparib significantly improves overall survival in patients with recurrent platinum-sensitive ovarian cancer, with a hazard ratio of 1.24 based on a meta-analysis of 7 randomized controlled trials involving 2406 patients.

However, the treatment is associated with a higher incidence of adverse events, particularly for grades 3 or higher, indicating that while olaparib is effective, it also carries a risk of significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Olaparib in the Treatment of Recurrent Platinum Sensitive Ovarian Cancer. Chen, Q., Li, X., Zhang, Z., et al.[2022]

Olaparib, an oral PARP-inhibitor, significantly improves progression-free survival in HER2-negative advanced breast cancer patients with BRCA1/2 mutations compared to standard chemotherapy, based on a randomized Phase III trial.

The trial also indicated an overall survival benefit for patients who had not received prior chemotherapy for metastatic disease, highlighting olaparib's potential as an effective treatment option in this specific patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olaparib for advanced breast cancer. Griguolo, G., Dieci, MV., Miglietta, F., et al.[2021]

In the BAROCCO trial involving 123 patients with recurrent platinum-sensitive ovarian cancer, the combination of cediranib and olaparib did not show superior progression-free survival (PFS) compared to paclitaxel chemotherapy, with median PFS of 5.6 months for the continuous cediranib-olaparib group and 3.1 months for the control group.

Despite not outperforming chemotherapy, the cediranib-olaparib combination was associated with a lower rate of treatment discontinuation due to adverse events (5% in the intermittent arm) and offers a potential non-chemotherapy treatment option for heavily pretreated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer. Colombo, N., Tomao, F., Benedetti Panici, P., et al.[2022]

The PROfound trial shows that testing for genetic alterations in homologous recombination, particularly BRCA1, BRCA2, and ATM, is beneficial for all patients with metastatic, castration-resistant prostate cancer (mCRPC).

Olaparib significantly improves progression-free survival, objective response rate, and time to pain progression in patients with these genetic alterations, marking it as the first effective treatment in a genomically-selected group for this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploiting defects in homologous recombination repair for metastatic, castration-resistant prostate cancer. Chau, V., Madan, RA., Figg, WD.[2021]

Citations

1. withpower.com withpower.com/trial/clinical-trial-match-list-intervention-for-cancer-research-access-8acd0

Clinical Trial Match-List Intervention for Cancer Research ... In the phase III OlympiAD trial, olaparib significantly improved progression-free survival (PFS) in patients with germline BRCA-mutated, HER2-negative ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12273118/

Development and implementation of cancer clinical trial ... In general, automated cancer screening and matching tools have proven to be accurate and effective in matching patients to potential clinical ...

3. fightcancer.org fightcancer.org/sites/default/files/CT_MatchingServicesWhitepaper_ACSCAN_May2018Web_0.pdf

An Overview of Cancer Clinical Trial Matching Services Summary. Clinical trial matching services facilitate patient enrollment in clinical trials by identifying potential trials for interested patients and their ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01030

National Estimates of the Participation of Patients With ... The overall estimated patient participation rate to cancer treatment trials was 7.1%. Patients with cancer participated in a wide variety of other studies.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1040842824000507

Patients' selection and trial matching in early-phase ... We review the tools and initiatives to increase patients' orientation and access to early phase cancer clinical trials, and to limit early discontinuation.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02000622

Study Details | NCT02000622 | Assessment of the Efficacy ... This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000ClinPharmR.pdf

206162 Clinical Pharmacology Review - accessdata.fda.gov The safety database includes 223 patients with gBRCA mutated ovarian cancer that received monotherapy olaparib from the aforementioned trials.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK594376/

Clinical Review - Olaparib (Lynparza) - NCBI - NIH Deaths were reported in 59 patients (6.4%) in the olaparib group and 86 patients (9.4%) in the placebo group. The median OS was not estimable in either ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2105215

Adjuvant Olaparib for Patients with BRCA1- or BRCA2- ... Safety data were consistent with known side effects of olaparib, with no excess serious adverse events or adverse events of special interest.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT02032823

Study Details | NCT02032823 | Olaparib as Adjuvant ... A randomised, double-blind, parallel group, placebo-controlled multi-centre phase III study to assess the efficacy and safety of olaparib versus placebo as ...