Clinical trial for Advanced Malignant Solid Neoplasm
Official title Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
ClinicalTrials.gov ID: NCT05564377
What this study is testing
What is Alpelisib?
This is an investigational medicine being studied as a potential treatment for advanced solid tumors. It is designed to block a specific protein in the body that helps cancer cells grow.
Also referred to as Piqray, Vijoce.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if matching patients to treatments based on their tumor’s genetic changes can help control the cancer and aid doctors in planning care.
- Who it's for
- People with locally advanced or advanced solid tumors that have progressed after at least one standard therapy or have no proven standard treatment.
- What's involved
- Participants will have a genetic test on their tumor. If a targetable mutation is found, they may be matched to a specific treatment in another clinical trial.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Patient must have measurable disease
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \>=...
- Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider
- All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
- Patients must have progressed on at least one line of standard systemic therapy OR
See the full eligibility criteria
- Patient must have measurable disease
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \>= 50% or Karnofsky performance status of \>= 50%
- Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider
- All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)
- Patients must have progressed on at least one line of standard systemic therapy OR
- Patients whose disease has no standard treatment that has been shown to prolong overall survival
- Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll...
- Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial
- Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response [CR] or partial response [PR]) to any intervening therapy after collection of the tissue
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR
- Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available
- NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions.
- NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Goodyear, Arizona, United States
- Kingman, Arizona, United States
- Jonesboro, Arkansas, United States
- Arroyo Grande, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Encinitas, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Woodland, California, United States
- Aurora, Colorado, United States
+ 311 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Mobile, Alabama, United States; Anchorage, Alaska, United States; Goodyear, Arizona, United States; Kingman, Arizona, United States; Jonesboro, Arkansas, United States and 325 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.