Targeted Therapy for Solid Tumors

Recruiting at 506 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Solid tumors, Advanced stage, others

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

Compensation: Varies

Number of Visits: 5

Duration: 28 days per cycle, up to 5 years

2900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for patients with advanced solid tumors by using genetic testing to match them with therapies targeting specific genetic mutations in their cancer. The researchers aim to find treatments that can control tumors and improve treatment planning. Participants may receive one of several medications, such as olaparib (a PARP inhibitor) or binimetinib (a MEK inhibitor), based on their genetic profile. Ideal candidates have solid tumors that have spread and have either not responded to standard treatments or have no other options known to improve survival. 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 access potentially effective therapies early.

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

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial have varying levels of available safety information. Here's a simple overview:

**Olaparib**: Studies indicate that olaparib is usually well-tolerated by patients with advanced solid tumors. Common side effects include nausea, fatigue, and anemia.

**Binimetinib**: Approved for use with another medication for certain types of skin cancer (melanoma), binimetinib has limited safety information when used alone for other conditions. Reported side effects include skin rash and diarrhea.

**Fulvestrant**: Approved for treating certain breast cancers, fulvestrant has a known safety profile. Common side effects include pain at the injection site and hot flashes.

**Ipatasertib**: Early studies suggest that ipatasertib is generally safe, but more information is needed. Reported side effects include diarrhea and fatigue.

**Leucovorin**: Often used to lessen the side effects of some chemotherapy drugs, leucovorin is considered safe with few side effects when used this way.

**Nilotinib**: Approved for certain blood cancers, nilotinib has a well-understood safety profile. Some patients experience mild side effects like rash and mild headaches.

**Palbociclib**: Widely used and approved for breast cancer, palbociclib is generally safe but can cause neutropenia, increasing the risk of infection.

**Selumetinib**: Approved for certain conditions, selumetinib has a known safety profile. Side effects can include vision problems and heart issues.

**Sotorasib**: Approved for certain lung cancers, sotorasib is generally well-tolerated. Some patients report mild side effects like diarrhea and fatigue.

Overall, while most of these drugs have been approved for other uses, side effects can vary, especially when used in new combinations or for different conditions. This Phase 2 trial aims to further study how well these treatments are tolerated in patients with specific genetic mutations in their tumors. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they target specific pathways in solid tumors that current treatments might not effectively address. Unlike standard chemotherapy that targets all rapidly dividing cells, drugs like olaparib focus on exploiting DNA repair weaknesses in cancer cells by inhibiting the enzyme PARP, offering a more targeted approach. Sotorasib, on the other hand, is groundbreaking as it specifically targets KRAS G12C mutations, which have long been considered "undruggable." This precision in targeting mutations makes these treatments potentially more effective and less toxic compared to traditional options, paving the way for more personalized cancer therapies.

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

Research shows that olaparib, which participants in this trial may receive, can help treat certain cancers, such as ovarian cancer, by extending the time patients live without their cancer worsening. In this trial, some participants will receive olaparib combined with alpelisib, which has shown promise for individuals with specific genetic mutations, though the overall benefits remain unclear. Binimetinib is another treatment option in this trial; when used with other drugs, it may help treat certain mutations, but its effectiveness alone is still under study. Sotorasib, especially when combined with panitumumab, is also being tested in this trial and has shown encouraging results in controlling tumors with KRAS mutations, demonstrating good response rates. These treatments target specific genetic mutations, offering new options for patients whose tumors have these characteristics. ^{6 7 8 9 10}

Who Is on the Research Team?

James M Ford

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have spread and are not responding to standard treatments or lack treatment options proven to extend life. Participants need available tumor tissue samples, must be in fair health (ECOG 0-2), and willing to undergo genetic testing of their tumors. It's not suitable for those who've had a good response to recent therapies.

Inclusion Criteria

My condition worsened after at least one standard treatment.

I am mostly active and can care for myself.

You need to have samples of your tumor preserved in a specific way.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Registration

Patients undergo tumor mutational screening of previously-collected tumor samples for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing.

2-4 weeks

1 visit (in-person)

Treatment

Patients with mutations targeted to investigational combination therapies are assigned to 1 of 20 treatment subprotocols. Treatment includes various drug administrations and monitoring procedures.

28 days per cycle, up to 5 years

Multiple visits per cycle (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up includes CT or MRI scans and blood sample collections.

Up to 3 years

Every 3 months for 2 years, then every 6 months for 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Binimetinib
• Biopsy
• Biospecimen Collection
• Bone Marrow Aspiration
• Bone Scan
• Computed Tomography
• Echocardiography
• Fluorouracil
• Fulvestrant
• Ipatasertib
• Leucovorin
• Magnetic Resonance Imaging
• Multigated Acquisition Scan
• Mutation Carrier Screening
• Nilotinib Hydrochloride Monohydrate
• Olaparib
• Oxaliplatin
• Paclitaxel
• Palbociclib
• Positron Emission Tomography
• Selumetinib Sulfate
• Sotorasib

Trial Overview

The ComboMATCH trial tests targeted therapies based on genetic mutations in patients' tumors. Various drugs like Oxaliplatin, Ipatasertib, and Olaparib are matched with specific genetic changes identified through testing. The study aims to control the tumor growth by personalizing treatment plans.

How Is the Trial Designed?

Group I: EAY191-S3 (activating AKT mutation) Experimental Treatment 6 Interventions

Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up.

Group II: EAY191-N5 Arm II (neratinib maleate,palbociclib) Experimental Treatment 8 Interventions

Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

Group III: EAY191-N4 Arm I (RAS pathway mutations) Experimental Treatment 10 Interventions

Patients receive selumetinib PO BID and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.

Group IV: EAY191-N2 Cohort II (NF1 mutations) Experimental Treatment 9 Interventions

Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.

Group V: EAY191-N2 Cohort I (Arm II) (NF1 mutations) Experimental Treatment 8 Interventions

Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.

Group VI: EAY191-N2 Cohort I (Arm I) (NF1 mutations) Experimental Treatment 9 Interventions

Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.

Group VII: EAY191-E5 Cohort II (sotorasib) Experimental Treatment 6 Interventions

Patients receive combination therapy as in EAY191-E5 Arm A.

Group VIII: EAY191-E5 Cohort I Arm A (sotorasib, panitumumab) Experimental Treatment 6 Interventions

Patients receive sotorasib PO QD on days 1-28 and panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.

Group IX: EAY191-E4 (taxane therapy) Experimental Treatment 6 Interventions

Patients receive nilotinib hydrochloride monohydrate PO BID on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening or cycle 1 day 1, every 2 cycles for 1 year, every 3 cycles for patients on study for more than 1 year, and every 4 cycles for patients on study for more than 3 years and may also undergo CT or MRI during follow-up every 3 months for 2 years and then every 6 months for 1 year if clinically indicated. Patients also undergo collection of blood samples at baseline, cycle 2 day 1, and optionally at progression as well as tumor biopsy at baseline and optionally at progression.

Group X: EAY191-A6 Arm II (RAS/RAF/MEK/ERK mutations) Experimental Treatment 11 Interventions

Patients receive binimetinib PO, leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or an FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated

Group XI: EAY191-A6 Arm I (RAS/RAF/MEK/ERK mutations) Experimental Treatment 11 Interventions

Patients receive leucovorin IV, oxaliplatin IV, and fluorouracil IV on study. Patients undergo ECHO and MUGA during screening and on study, a CT with contrast, MRI, or a FDG-PET during screening, collection of blood during screening and on study, and a biopsy during screening. Patients may also undergo brain MRI or CT during screening and on study, bone scans on study, and biopsy on study if clinically indicated.

Group XII: EAY191-A3 Monotherapy Cohort 1 (binimetinib) Experimental Treatment 6 Interventions

Patients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.

Group XIII: EAY191-A3 Combo Cohorts 1, 2, 3, 4 (palbociclib, binimetinib) Experimental Treatment 6 Interventions

Patients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.

Group XIV: EAY191-A2 (Cohort 3, Arm D) Experimental Treatment 7 Interventions

Cohort 3, Arm D: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

Group XV: EAY191-A2 (Cohort 2, Arm C) Experimental Treatment 7 Interventions

Cohort 2, Arm C: Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients experiencing disease progression have the option to migrate to Cohort 3, Arm D. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

Group XVI: EAY191-A2 (Cohort 2, Arm B) Experimental Treatment 8 Interventions

Cohort 2, Arm B: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

Group XVII: EAY191-A2 (Cohort 1, Arm A) Experimental Treatment 8 Interventions

Cohort 1, Arm A: Patients receive olaparib PO BID and alpelisib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 5 years in the absence of disease progression, unacceptable toxicity, or bone marrow findings consistent with MDS or AML. Patients also undergo MRI, CT, and/or PET scans throughout the trial and a biopsy prior to treatment start. Patients may also undergo bone scans on study as clinically indicated. Patients have the option to also undergo blood collection throughout the trial and a second biopsy at time of disease progression.

Group XVIII: EAY191-N5 Arm I (neratinib maleate) Active Control 7 Interventions

Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

Group XIX: EAY191-E5 Cohort I Arm B (sotorasib) Active Control 5 Interventions

Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.

Group XX: EAY191-N4 Arm II (RAS pathway mutations) Active Control 9 Interventions

Patients receive selumetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may elect to cross over to Arm I provided they have not had dose limiting toxicities to monotherapy selumetinib. Patients also undergo a tumor biopsy and blood collection during screening and on study, as well as ECHO or MUGA, and CT scans throughout the trial. Patients may undergo bone marrow aspiration or biopsy as clinically indicated.

Binimetinib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

Approved in European Union as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Approved in Canada as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

Approved in Japan as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a phase Ib study involving 89 patients with advanced solid tumors, the combination of binimetinib (a MEK inhibitor) and buparlisib (a PI3K inhibitor) showed some efficacy, particularly in RAS/BRAF-mutant ovarian cancer, where 12% of patients achieved a partial response.

However, the treatment was associated with significant toxicities, leading to a lower than expected dose intensity, suggesting that alternative dosing strategies, like pulsatile dosing, may be necessary to improve safety and tolerability in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase Ib Study of Combination Therapy with MEK Inhibitor Binimetinib and Phosphatidylinositol 3-Kinase Inhibitor Buparlisib in Patients with Advanced Solid Tumors with RAS/RAF Alterations. Bardia, A., Gounder, M., Rodon, J., et al.[2023]

Targeted and immunological therapies have significantly improved survival rates in patients with solid tumors, demonstrating the effectiveness of treatments that focus on specific genetic and immunological changes in tumors.

Current clinical trials are exploring the optimal timing and sequencing of these therapies, which include various approved agents for cancers like prostate, breast, lung, and melanoma, indicating a shift towards more personalized cancer treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacotherapy of solid tumors. New hopes and frustrations]. Grünwald, V., Rickmann, M.[2021]

A 67-year-old male patient with heavily pre-treated metastatic non-small cell lung carcinoma showed a major disease response after six months of treatment with sunitinib, a multitargeted tyrosine kinase inhibitor.

Sunitinib demonstrated a good safety profile with no high-grade toxicities, making it a promising option for patients with limited treatment choices in advanced lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response and safety of sunitinib in a heavily pre-treated metastatic non-small cell lung carcinoma patient. Tassi, R., Muto, A., Rangan, S., et al.[2018]

For patients with relapsed or progressive non-small cell lung cancer (NSCLC), treatment options are limited after conventional chemotherapy, with only erlotinib and crizotinib approved as third-line therapies in the U.S.

The review emphasizes the importance of identifying molecular characteristics of tumors to improve the effectiveness of targeted therapies, suggesting that agents affecting multiple pathways may offer significant clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted agents in the third-/fourth-line treatment of patients with advanced (stage III/IV) non-small cell lung cancer (NSCLC). Langer, CJ., Mok, T., Postmus, PE.[2022]

In a study involving patients with advanced solid tumors, the combination of sunitinib at 37.5 mg per day and irinotecan showed some antitumor activity, with 3 out of 10 patients responding, but it also caused significant side effects like neutropenia and sepsis.

The lower dose of sunitinib at 25 mg per day was better tolerated with no dose-limiting toxicities, but it did not demonstrate any antitumor activity, leading to the conclusion that this combination therapy will not be further investigated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I, dose-finding study of sunitinib in combination with irinotecan in patients with advanced solid tumours. Boven, E., Massard, C., Armand, JP., et al.[2021]

In a phase I study involving 26 patients with metastatic colorectal cancer, the combination of oral binimetinib and FOLFOX was found to have a maximum tolerated dose of 45 mg taken twice daily, with no dose-limiting toxicities observed.

The treatment showed some antitumor activity, with 9 out of 13 patients on continuous dosing achieving stable disease after 2 months, and a median progression-free survival of 3.5 months, indicating potential efficacy in heavily pretreated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I clinical trial of binimetinib in combination with FOLFOX in patients with advanced metastatic colorectal cancer who failed prior standard therapy. Cho, M., Gong, J., Frankel, P., et al.[2022]

In a phase II study involving 98 patients with BRAFV600E-mutant metastatic non-small-cell lung cancer (NSCLC), the combination of encorafenib and binimetinib achieved a confirmed objective response rate of 75% in treatment-naïve patients and 46% in previously treated patients, indicating significant efficacy.

The treatment was generally well-tolerated, with common side effects including nausea (50%) and diarrhea (43%), but it also led to dose reductions in 24% of patients and one serious adverse event of intracranial hemorrhage, highlighting the importance of monitoring safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non-Small-Cell Lung Cancer. Riely, GJ., Smit, EF., Ahn, MJ., et al.[2023]

Binimetinib, an uncompetitive inhibitor of MEK1/2, has shown significant efficacy in treating metastatic melanoma, particularly in combination with encorafenib, resulting in a progression-free survival (PFS) of 14.9 months compared to 7.3 months with vemurafenib alone in Phase 3 trials.

While binimetinib has a tolerable safety profile, there is currently no long-term data on durable responses or overall survival benefits compared to other treatments, highlighting the need for individualized treatment plans for patients with BRAF-mutated metastatic melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The discovery and development of binimetinib for the treatment of melanoma. Tran, B., Cohen, MS.[2021]

The phase I study found that the MEK inhibitor binimetinib, when combined with carboplatin and pemetrexed, has a recommended phase II dose of 30 mg BID and shows manageable toxicity, with 61.5% of patients experiencing grade 3/4 adverse events.

The treatment demonstrated promising efficacy, with a 50% objective response rate and an 83.3% disease control rate in patients with advanced non-squamous NSCLC, particularly in those with KRAS/NRAS mutations, who had a higher response rate of 62.5%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I study of binimetinib (MEK 162), a MEK inhibitor, plus carboplatin and pemetrexed chemotherapy in non-squamous non-small cell lung cancer. Fung, AS., Graham, DM., Chen, EX., et al.[2021]

In a phase 1 study involving 93 patients with advanced solid tumors, binimetinib was found to have a maximum tolerated dose (MTD) of 60 mg twice daily, but the recommended dose for further studies was adjusted to 45 mg due to ocular toxicity.

Binimetinib showed a manageable safety profile with common side effects including rash and nausea, and demonstrated preliminary anti-tumor activity with three patients with biliary cancer achieving objective responses, indicating potential for further investigation in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 dose-escalation and expansion study of binimetinib (MEK162), a potent and selective oral MEK1/2 inhibitor. Bendell, JC., Javle, M., Bekaii-Saab, TS., et al.[2022]

In a study involving six patients with EGFR-mutated lung adenocarcinoma, the combination of osimertinib and ramucirumab was found to be generally safe, with only one case of dose-limiting toxicity (grade 3 appetite loss) and no other severe adverse events reported.

Five out of six patients showed a partial response to the treatment, with a median progression-free survival of 9.2 months for those with the EGFR T790M mutation, suggesting promising efficacy that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase Ib Study of Osimertinib Plus Ramucirumab in Japanese Lung Cancer Patients With EGFR Mutation. Akamatsu, H., Ozawa, Y., Oyanagi, J., et al.[2023]

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