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ALK Inhibitor

Targeted Therapy + Immunotherapy for Advanced Cancer

Phase 2

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment

For participants aged >= 18 and <18 years: adequate hematologic and end-organ function

Must not have

Stereotactic radiosurgery within 7 days prior to start of study treatment

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately up to 12 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study the safety and efficacy of targeted therapies or immunotherapy for people with unresectable, locally advanced or metastatic solid tumors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects depend on the specific drugs given but may include fatigue, nausea, diarrhea, skin reactions, liver issues, blood clots and an increased risk of infections. Some treatments might also cause allergic reactions or affect heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened after treatment or I haven't been treated because there are no suitable options.

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My blood and organs are functioning well.

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I am active and can care for myself regardless of my age.

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I am active and can care for myself regardless of my age.

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My cancer is advanced, cannot be surgically removed, and has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a precise radiation treatment within the last week.

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I am still recovering from a surgery that might affect the study's treatment.

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I do not have serious heart conditions or recent heart attacks.

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I haven't had another active cancer in the last 5 years that could affect this study.

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I have not had whole brain radiotherapy in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately up to 12 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately up to 12 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately up to 12 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Secondary study objectives

All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

All Cohorts: Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)

All Cohorts: Time to confirmed symptom onset or worsening from tumor-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

14Treatment groups

Experimental Treatment

Group I: Cohort N: SETD2 Loss of Function tumorsExperimental Treatment1 Intervention

Participants with SETD2 Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).

Group II: Cohort M: ATM Loss of Function tumorsExperimental Treatment1 Intervention

Participants with ATM Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).

Group III: Cohort L: KRAS G12C-positive tumors (excluding NSCLC and CRC)Experimental Treatment1 Intervention

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

Group IV: Cohort K: RET fusion-positive tumors (excluding NSCLC)Experimental Treatment1 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 patients ≥ 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 tumorsExperimental Treatment1 Intervention

Participants with BRAF class III mutant-positive tumors(adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) 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 tumorsExperimental Treatment1 Intervention

Participants with BRAF class II mutant/fusion-positive tumors (adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) 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 I has been closed for enrollment

Group VII: Cohort H: PIK3CA multiple mutant-positive tumorsExperimental Treatment1 Intervention

Participants with metastatic or advanced solid tumors will receive 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 G: MDM2-amplified, TP53 wild-type tumorsExperimental Treatment1 Intervention

Participants with metastatic or advanced solid tumors will receive idasanutlin at a dose of 250 mg orally QD on Days 1-5 of each 28-day cycle. Note: Cohort G has been closed for enrollment

Group IX: Cohort F: HER2 mutant-positive tumorsExperimental Treatment1 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 for enrollment

Group X: Cohort E: AKT1/2/3 mutant-positive tumorsExperimental Treatment1 Intervention

Participants with metastatic or advanced solid tumors will receive ipatasertib orally once daily (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 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 XI: Cohort D: TMB-high tumorsExperimental Treatment1 Intervention

Participants with metastatic or advanced solid tumors will receive atezolizumab intravenously (IV) at a fixed dose 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. Note: Cohort D has been closed for enrollment

Group XII: Cohort C: ALK fusion-positive tumors (excluding NSCLC)Experimental Treatment1 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 XIII: Cohort B: NTRK1/2/3 fusion-positive tumorsExperimental Treatment1 Intervention

Participants with metastatic or advanced solid tumors will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 mg/day for adults and pediatric participants with a BSA \>/= 1.51 m2. The total dose of daily entrectinib administration for pediatric participants with BSA\<1.51 m2 will be lower.

Group XIV: Cohort A: ROS1 Fusion-positive tumors (excluding NSCLC)Experimental Treatment1 Intervention

Participants with metastatic or advanced solid tumors, with the exception of NSCLC will receive entrectinib once daily 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 squaremeter (m2). The total dose of daily entrectinib administration for pediatric participants with BSA\<1.51 m2 will be lower.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipatasertib

2017

Completed Phase 3

~3630

Idasanutlin

2018

Completed Phase 2

~410