Targeted Therapy + Immunotherapy for Advanced Cancer

Recruiting at 159 trial locations

Overseen By Reference Study ID Number: BO41932 https://forpatients.roche.com/

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Disqualifiers: Cardiovascular disease, Active cancer, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles

920 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of certain targeted drugs and immunotherapies for individuals with advanced cancer that cannot be surgically removed or has spread. It aims to determine the safety and efficacy of these treatments by matching them to the genetic changes in a person's tumor. The trial includes several groups, each focusing on different genetic alterations in the cancer, so the treatment received will depend on these specific changes. Suitable candidates have tumors that have spread or cannot be removed and have shown specific genetic changes in tests. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had any anticancer treatment within 2 weeks or 5 half-lives before starting the study treatment.

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

Research has shown that entrectinib is generally well-tolerated in patients with advanced solid tumors, including those with specific genetic fusions. One study found that taking 600 mg/day of entrectinib is safe, with common side effects like mild to moderate tiredness or dizziness being manageable. Serious side effects are rare and often depend on the individual's health.

For alectinib, research indicates it is safe for treating tumors with ALK (anaplastic lymphoma kinase) changes. Patients usually handle it well, with most side effects being mild, such as constipation or swelling. Severe side effects are uncommon but can include liver issues.

Atezolizumab, an immunotherapy, has a safety record based on data from thousands of patients. It is mostly well-tolerated, with some patients experiencing side effects like tiredness or reduced appetite. Serious side effects are rare and can include immune-related responses affecting organs.

Ipatasertib has shown a manageable safety profile in people with certain gene mutations. It is generally safe, with side effects like diarrhea or vomiting being the most reported. These are usually mild or moderate.

Trastuzumab emtansine, used for treating HER2-positive cancers, is FDA-approved and generally safe. Common side effects include tiredness and nausea, while serious side effects like liver damage are rare.

Inavolisib has been tested and shown to be well-tolerated. Its safety profile indicates few severe side effects, with common ones being mild, such as nausea or tiredness.

Belvarafenib is another drug with a favorable safety profile. Patients typically experience mild side effects like rash or joint pain. Serious side effects are rare.

Pralsetinib is FDA-approved for certain cancers and is generally safe. Most side effects are mild, such as high blood pressure or tiredness. Severe side effects are uncommon but can include liver problems.

These treatments have been tested in various studies, showing they are generally safe and well-tolerated for most patients. However, individual experiences can vary, and discussing any concerns with healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer targeted approaches for advanced cancer, focusing on specific genetic mutations. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, these investigational therapies target precise genetic alterations. Entrectinib, for example, is designed for ROS1 and NTRK fusion-positive tumors, aiming directly at the fusion proteins that drive cancer growth. Alectinib targets ALK fusion-positive tumors with a unique mechanism that specifically inhibits ALK activity. These targeted therapies are promising because they offer the potential for more effective treatment with potentially fewer side effects by honing in on the cancer's unique genetic makeup.

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

In this trial, participants will receive treatments based on specific genetic changes in their tumors. Entrectinib, administered to participants in Cohorts A and B, previously helped 81.1% of patients with tumors having NTRK and ROS1 fusions. Alectinib, given to participants in Cohort C, has slowed cancer spread and improved survival in some cancer types. Atezolizumab, used in Cohort D, works well for tumors with many mutations, leading to long-lasting effects. Ipatasertib, provided to participants in Cohort E, has effectively shrunk tumors with specific genetic changes. Pralsetinib, used in Cohort K, showed a 46.4% success rate in treating tumors with RET fusions. Each treatment targets specific genetic changes, offering hope for personalized cancer care. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

Adults and children with advanced, inoperable or metastatic solid tumors that have specific genetic changes identified by a special test. They must be physically able to participate (with varying performance scores based on age), have no other treatments available or have progressed after treatment, and not be pregnant or breastfeeding. Participants need to agree to use effective contraception.

Inclusion Criteria

For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period

I am a man willing to use contraception or remain abstinent as required.

Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)

Exclusion Criteria

History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study

I haven't had cancer treatment in the last 2 weeks or 5 half-lives before starting this study.

Pregnant or breastfeeding, or intending to become pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive targeted therapies or immunotherapy based on their genetic alterations in repeated cycles until disease progression or other discontinuation criteria are met

28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately up to 12 years

What Are the Treatments Tested in This Trial?

Interventions

• Alectinib
• Atezolizumab
• Belvarafenib
• Entrectinib
• Idasanutlin
• Inavolisib
• Ipatasertib
• Pralsetinib
• Trastuzumab emtansine

Trial Overview The TAPISTRY trial is testing how well different targeted therapies or immunotherapies work for patients whose tumors have certain genomic alterations or high mutation burdens. Patients receive personalized treatment based on their tumor's genetic profile, which could include drugs like Ipatasertib, Atezolizumab, etc., alone or combined.

How Is the Trial Designed?

Group I: Cohort N: SETD2 LOF Tumors Experimental Treatment 1 Intervention

Participants with methyltransferase SET (Su(var) 3-9) Enhancer of zest and Trithorax) domain-containing 2 (SETD2) LOF tumors will self-administer camonsertib orally at home (except on clinic days).

Group II: Cohort M: Ataxia-telangiectasia Mutated (ATM) Loss of Function (LOF) Tumors Experimental Treatment 1 Intervention

Participants with ATM LOF tumors will self-administer camonsertib orally at home (except on clinic days).

Group III: Cohort L: KRAS G12C-positive Tumors (Excluding NSCLC and Colorectal Cancer [CRC]) Experimental Treatment 1 Intervention

Participants with kirsten rat sarcoma virus (KRAS) G12C-positive tumors will self-administer divarasib (GDC-6036) orally at home (except on clinic days).

Group IV: Cohort K: Rearranged During Transfection (RET) Fusion-positive Tumors (Excluding NSCLC) Experimental Treatment 1 Intervention

Participants with RET fusion-positive tumors will self-administer pralsetinib orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric participants ≥ 12 and \< 18 years of age. A treatment cycle consists of 4 weeks (28 days). Note: Cohort K has been closed for enrollment.

Group V: Cohort J: BRAF Class III Mutant-positive Tumors Experimental Treatment 1 Intervention

Participants with BRAF class III mutant-positive tumors (adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib PO BID with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle. Note: Cohort J has been closed for enrollment.

Group VI: Cohort I: BRAF Class II Mutant or Fusion-positive Tumors Experimental Treatment 1 Intervention

Participants with proto-oncogene B-Raf (BRAF) class II mutant/fusion-positive tumors (adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib, PO, BID with adequate water (more than 200 milliliters \[mL\]). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle. Note: Cohort I has been closed for enrollment.

Group VII: Cohort H: PIK3CA Multiple Mutant-positive Tumors Experimental Treatment 1 Intervention

Participants with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) multiple mutant-positive tumors will receive inavolisib (GDC-0077) QD at a starting dose of 9 mg by mouth (PO) in repeated 28-day cycles. Note: Cohort H has been closed for enrollment.

Group VIII: Cohort F: Human Epidermal Growth Factor Receptor 2 (HER2) Mutant-positive Tumors Experimental Treatment 1 Intervention

Participants with metastatic or advanced solid tumors will receive trastuzumab emtansine IV at a dose of 3.6 mg/kg every 21 days. Note: Cohort F has been closed as of protocol version 7 because enrollment and participant follow-up have been completed.

Group IX: Cohort E: Protein Kinase B (AKT) 1/2/3 Mutant-positive Tumors Experimental Treatment 1 Intervention

Participants with metastatic or advanced solid tumors will receive ipatasertib orally, QD at the starting dose of 400 mg in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent. For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants \< 35 kilograms (kg), 300 mg for participants ≥ 35 and \< 45 kg, 400 mg for those ≥ 45 kg orally QD in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent. Note: Cohort E has been closed for enrollment.

Group X: Cohort D: TMB-high Tumors Experimental Treatment 1 Intervention

Participants with metastatic or advanced solid tumors will receive atezolizumab intravenously (IV) at a fixed dose for participants aged ≥ 18 years, and 15 milligrams per kilogram (mg/kg) (maximum 1200 mg) for participants aged \< 18 years on Day 1 of each 21-day cycle. Note: Cohort D has been closed for enrollment.

Group XI: Cohort C: Anaplastic Lymphoma Kinase (ALK) Fusion-positive Tumors (Excluding NSCLC) Experimental Treatment 1 Intervention

Participants with metastatic or advanced solid tumors, with the exception of NSCLC, will receive alectinib at a dosage of 600 mg, orally, twice a day (BID), taken with food, in repeated 28-day cycles.

Group XII: Cohort B: Neurotrophic Tyrosine Receptor Kinase (NTRK) 1/2/3 Fusion-positive Tumors Experimental Treatment 1 Intervention

Participants with metastatic or advanced solid tumors will receive entrectinib, QD in repeated 28-day cycles at a dose of 600 mg/day for adults and pediatric participants with a BSA ≥ 1.51 m\^2. The total dose of daily entrectinib administration for pediatric participants with BSA \< 1.51 m\^2 will be lower.

Group XIII: Cohort A: ROS Proto-oncogene 1 (ROS1) Fusion-positive Tumors (Excluding NSCLC) Experimental Treatment 1 Intervention

Participants with metastatic or advanced solid tumors, with the exception of non-small cell lung cancer (NSCLC), will receive entrectinib once daily (QD) in repeated 28-day cycles at a dose of 600 milligram per day (mg/day) for adults and pediatric participants with a body surface area (BSA) ≥ 1.51 square meter (m\^2). The total dose of daily entrectinib administration for pediatric participants with BSA \< 1.51 m\^2 will be lower.

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

Approved in United States as Alecensa for:

• Metastatic ALK-positive non-small cell lung cancer (NSCLC)
• Adjuvant treatment following tumor resection in patients with ALK-positive NSCLC

Approved in European Union as Alecensa for:

• Metastatic ALK-positive non-small cell lung cancer (NSCLC)
• Adjuvant treatment following tumor resection in patients with ALK-positive NSCLC

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

The ASTEFANIA trial is designed to assess the effectiveness of combining atezolizumab, an immunotherapy, with ado-trastuzumab emtansine in treating high-risk, HER2-positive early breast cancer patients who have residual disease after initial HER2-targeted therapy.

This study will involve 1700 participants across 32 countries, focusing on invasive disease-free survival as the primary outcome, while also evaluating safety and pharmacokinetics, highlighting the potential for enhanced treatment strategies in early-stage breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ASTEFANIA: adjuvant ado-trastuzumab emtansine and atezolizumab for high-risk, HER2-positive breast cancer. Hurvitz, SA., Bachelot, T., Bianchini, G., et al.[2022]

In a study of 110 patients with HER2-positive metastatic breast cancer who had previously received multiple treatments, the antibody-drug conjugate trastuzumab emtansine (T-DM1) showed an overall response rate of 34.5% and a clinical benefit rate of 48.2%, indicating its effectiveness as a treatment option.

T-DM1 was well tolerated, with most side effects being mild (grades 1 to 2), and the most common severe side effects included thrombocytopenia and fatigue, suggesting a favorable safety profile for patients who have exhausted other HER2-targeted therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of trastuzumab emtansine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who were previously treated with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. Krop, IE., LoRusso, P., Miller, KD., et al.[2022]

In the phase III KAITLIN study involving 1846 adults with high-risk HER2-positive early breast cancer, replacing taxanes and trastuzumab with trastuzumab emtansine (T-DM1) did not significantly improve invasive disease-free survival compared to the standard treatment of trastuzumab plus pertuzumab with chemotherapy.

While both treatment regimens showed favorable outcomes, the completion rate for the T-DM1 group was lower (65.0%) due to more laboratory abnormalities, indicating potential safety concerns despite similar rates of serious adverse events between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study. Krop, IE., Im, SA., Barrios, C., et al.[2023]

In a phase 3 trial involving 1486 patients with HER2-positive early breast cancer, adjuvant treatment with trastuzumab emtansine (T-DM1) significantly reduced the risk of invasive disease or death by 50% compared to trastuzumab alone, with 12.2% of patients in the T-DM1 group experiencing these events versus 22.2% in the trastuzumab group.

The estimated 3-year invasive disease-free survival rate was 88.3% for the T-DM1 group compared to 77.0% for the trastuzumab group, indicating that T-DM1 is more effective in preventing recurrence after neoadjuvant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. von Minckwitz, G., Huang, CS., Mano, MS., et al.[2022]

The combination of atezolizumab with trastuzumab emtansine did not significantly improve progression-free survival in patients with HER2-positive metastatic breast cancer compared to trastuzumab emtansine alone, with a median survival of 8.2 months versus 6.8 months, indicating no clinically meaningful benefit.

Patients receiving atezolizumab experienced a higher frequency of adverse events, including serious complications, suggesting that this combination therapy may pose additional risks without clear advantages in efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated, HER2-positive advanced breast cancer (KATE2): a phase 2, multicentre, randomised, double-blind trial. Emens, LA., Esteva, FJ., Beresford, M., et al.[2020]

In a study of 232 Japanese patients with HER2-positive advanced breast cancer, trastuzumab emtansine (T-DM1) was found to be well tolerated, with 98.3% of patients experiencing adverse events but only 2.2% discontinuing treatment due to these events.

The most common serious adverse effects included thrombocytopenia in 29.7% of patients and hepatotoxicity in 11.2%, but no new safety concerns were identified, indicating that T-DM1 is a viable treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Evaluation of Trastuzumab Emtansine in Japanese Patients with HER2-Positive Advanced Breast Cancer. Watanabe, J., Ito, Y., Saeki, T., et al.[2022]

Trastuzumab emtansine (T-DM1) has shown a favorable safety profile in 884 patients with HER2-positive metastatic breast cancer, with most adverse events being manageable and asymptomatic, such as fatigue and nausea.

The treatment demonstrated superior efficacy compared to standard therapies in previous studies, making T-DM1 a promising option for further exploration in other breast cancer settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trastuzumab emtansine in human epidermal growth factor receptor 2-positive metastatic breast cancer: an integrated safety analysis. Diéras, V., Harbeck, N., Budd, GT., et al.[2019]

In a study involving 27 patients with HER2-positive metastatic breast cancer who had progressed on previous therapies, the combination of ado-trastuzumab emtansine (T-DM1) and neratinib showed promising efficacy, with 63% of evaluable patients achieving an objective response.

The recommended phase II dose for this combination was established as T-DM1 at 3.6 mg/kg and neratinib at 160 mg/d, with manageable safety profiles, although some patients experienced grade 3 toxicities like diarrhea and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of T-DM1 Plus Neratinib in Patients With Metastatic HER2-Positive Breast Cancer: NSABP Foundation Trial FB-10. Abraham, J., Montero, AJ., Jankowitz, RC., et al.[2020]

Atezolizumab, when combined with other therapies like trastuzumab and docetaxel, showed promising safety and efficacy in treating patients with HER2-positive metastatic breast cancer, with objective responses observed in 6 out of 6 patients in one cohort.

In early breast cancer patients, the combination of atezolizumab with trastuzumab or T-DM1 increased PD-L1 levels and CD8+ T-cell infiltration, suggesting that this treatment may enhance the immune response, although it did not promote T-cell receptor clonal expansion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Anti-HER2 Treatments Combined With Atezolizumab on the Tumor Immune Microenvironment in Early or Metastatic Breast Cancer: Results From a Phase Ib Study. Hamilton, EP., Kaklamani, V., Falkson, C., et al.[2022]

In a phase Ib trial involving 20 patients with HER2-positive metastatic breast cancer, the combination of trastuzumab emtansine (T-DM1) and pembrolizumab was found to be safe and tolerable, with no dose-limiting toxicities reported.

The treatment resulted in an objective response rate of 20% and a median progression-free survival of 9.6 months, indicating potential efficacy, although immune biomarkers did not correlate with treatment response in this small cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer. Waks, AG., Keenan, TE., Li, T., et al.[2022]

Ado-trastuzumab emtansine (T-DM1) was approved in the U.S. for treating HER2 positive metastatic breast cancer based on the EMILIA phase III trial, which showed it was more effective than the standard treatment of lapatinib plus capecitabine.

Ongoing and planned trials are exploring T-DM1's use in various stages of breast cancer, and the review discusses its toxicity management and potential resistance mechanisms, highlighting its importance in current cancer treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ado-trastuzumab emtansine (T-DM1) in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer: latest evidence and clinical potential. Peddi, PF., Hurvitz, SA.[2022]

In a phase IIa study involving 64 patients with HER2-positive metastatic breast cancer, the combination of trastuzumab emtansine (T-DM1) and pertuzumab showed an overall objective response rate (ORR) of 41%, with a higher ORR of 57% in first-line patients, indicating promising efficacy for this treatment.

The combination therapy was generally safe, with common side effects including fatigue (61%) and nausea (50%), and no unexpected toxicities were reported, suggesting that this treatment can be administered at full doses without significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IIa trial of trastuzumab emtansine with pertuzumab for patients with human epidermal growth factor receptor 2-positive, locally advanced, or metastatic breast cancer. Miller, KD., Diéras, V., Harbeck, N., et al.[2022]

Citations

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Survival results for ALECENSA® (alectinib) PFS by IRC: In the ITT population, mPFS was 25.7 months for ALECENSA (95% CI: 19.9, NE) compared with 10.4 months with crizotinib (95% CI: 7.7, ...

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Real-world usage and clinical outcomes of alectinib among ... The objective response rate was higher than in clinical trials (67.1% vs 51.3%, respectively) as was the disease control rate (89.9% vs 78.8%, respectively), ...

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Results across endpoints Results across endpoints · ALECENSA was effective in delaying CNS metastases · Primary analysis · ALECENSA reduced the risk of CNS metastases vs crizotinib | IRC.

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Updated Efficacy and Safety Data and Impact of the EML4 ... Overall, 119 of 152 alectinib-treated patients (78.3%) had a PR compared with 111 of 151 crizotinib-treated patients (73.5%) (Fig. 2). The ...

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ALECENSA® (alectinib) safety profile A retrospective cohort study using electronic health record data in 117 adult patients with ALK-positive advanced NSCLC receiving ALK TKIs, with ALECENSA (n=70) ...

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