Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Plain English Summary

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study is a Phase 2 clinical trial sponsored by Hoffmann-La Roche studying Solid Tumors. This trial tests if specific targeted drugs or immunotherapies work for advanced solid tumors based on their genetic makeup. It is for patients with advanced or metastatic solid tumors that have specific genetic changes or high tumor mutation burden. Participation involves receiving a treatment tailored to your tumor's genetic profile, with regular check-ups and monitoring. Alternative treatments may include standard chemotherapy, radiation, or other targeted therapies depending on your specific cancer type and stage. The trial aims to enroll 920 participants.

Official Summary

TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have a confirmed diagnosis of advanced or metastatic solid tumors and your tumor has specific genetic alterations or high tumor mutational burden. You cannot join if you are currently in another cancer treatment trial, have had recent radiation therapy, or are pregnant or breastfeeding. Patients aged 16 and older with a good performance status (able to perform daily activities) and adequate organ function are eligible. Specific health conditions and prior cancer treatments may exclude you, as determined by the study doctor. This trial is studying Solid Tumors, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how many patients have their tumors shrink or disappear in response to the treatment, indicating the treatment's effectiveness in controlling the cancer. The specific primary outcome measures are: All Cohorts: Independent Review Committee (IRC)-assessed Objective Response Rate (ORR) Based on Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (Approximately up to 12 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial matters because it aims to find the most effective treatment for each patient's cancer by matching therapies to specific genetic targets, filling a gap in personalized cancer care. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Solid Tumors, where improved treatment options are needed.

Investor Insight

This trial represents a significant investment in precision oncology, targeting a large market of patients with solid tumors and aiming to establish new standards of care, with a moderate probability Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval. The large enrollment target of 920 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific genetic tests used and what the results mean for your treatment options. Understand the schedule of visits, tests, and potential side effects associated with the assigned treatment. Be prepared for regular monitoring of your tumor's response and your overall health throughout the study. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 920 participants

Interventions

• DRUG: Entrectinib — Adults and pediatric participants with a BSA ≥1.51 m\^2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA \< 1.51 m\^2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m\^2) or 300 mg/day (BSA=0.81-1.10 m\^2) or 200 mg/day (BSA=0.51-0.80 m\^2) or 300 milligrams per square meter (mg/m\^2) (BSA=0.43-0.50 m\^2).
• DRUG: Entrectinib — Adults and pediatric participants with a BSA ≥ 1.51 m\^2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA \< 1.51 m\^2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m\^2) or 300 mg/day (BSA=0.81-1.10 m\^2) or 200 mg/day (BSA=0.51-0.80 m\^2) or 300 mg/m\^2 (BSA=≤0.50 m\^2).
• DRUG: Alectinib — Alectinib will be administered orally BID with food at a dosage of 600 mg (four 150-mg capsules).
• DRUG: Atezolizumab — Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg for participants aged ≥18 years, and 15 mg/kg (maximum 1200 mg) for participants aged \<18 years on Day 1 of each 21-day cycle.
• DRUG: Ipatasertib — For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants \< 35 kg, 300 mg for participants ≥35 and \< 45 kg, 400 mg for those ≥ 45 kg orally QD, beginning of Cycle 1, on Days 1-21 of each 28-day cycle until the participant experiences disease progression, intolerable toxicity, or withdraws consent.

Primary Outcomes

• All Cohorts: Independent Review Committee (IRC)-assessed Objective Response Rate (ORR) Based on Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (Approximately up to 12 years)

Secondary Outcomes

• All Cohorts: IRC-assessed Duration of Response (DOR) per RECIST v1.1 (Approximately up to 12 years)
• All Cohorts: IRC-assessed Clinical Benefit Rate (CBR) per RECIST v1.1 (Approximately up to 12 years)
• All Cohorts: IRC-assessed Progression-free Survival (PFS) per RECIST v1.1 (Approximately up to 12 years)
• All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1 (Approximately up to 12 years)
• All Cohorts: INV-assessed DOR per RECIST v1.1 (Approximately up to 12 years)

Full Eligibility Criteria

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
* Measurable disease as defined by RECIST v1.1, RANO, or INRC
* Performance status as follows: Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participants aged 16 to \< 18 years: Karnofsky score ≥ 50%; Participants aged \< 16 years: Lansky score ≥ 50%
* For participants aged ≥ 18 and \< 18 years: adequate hematologic and end-organ function
* Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
* Adequate recovery from most recent systemic or local treatment for cancer
* Life expectancy ≥ 8 weeks
* Ability to comply with the study protocol, in the investigator's judgment
* 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
* For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
* In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort

Exclusion Criteria:

* Current participation or enrollment in another therapeutic clinical trial
* Any anticancer treatment within 2 weeks or 5 half-lives prior to start of study treatment
* Whole brain radiotherapy within 14 days prior to start of study treatment
* Stereotactic radiosurgery within 7 days prior to start of study treatment
* Pregnant or breastfeeding, or intending to become pregnant during the study
* 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
* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
* History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy
* In addition to the general exclusion criteria above, in order to be enrolled in a treatment cohort of the study, participants must not meet any of the cohort-specific exclusion criteria

Trial Locations

• Western Regional Medical Center at Cancer Treatment Centers of America, Goodyear, Arizona, United States
• Kaiser Permanente Los Angeles, Los Angeles, California, United States
• USC Norris Cancer Center, Los Angeles, California, United States
• Hoag Memorial Hospital, Newport Beach, California, United States
• UC Davis Comprehensive Cancer Center, Sacramento, California, United States
• University Cancer & Blood Center, LLC, Athens, Georgia, United States
• St. Alphonsus, Boise, Idaho, United States
• Midwestern Regional Med Center, Zion, Illinois, United States
• Horizon Oncology Research, Inc., Lafayette, Indiana, United States
• Maryland Hematology & Oncology. P.A., Silver Spring, Maryland, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Solid Tumors
• Cancer
• Oncology
• Metastatic Cancer
• Advanced Cancer
• Genomic Alterations
• Tumor Mutational Burden
• Targeted Therapy
• Immunotherapy
• Precision Medicine

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