Recruiting NCT07415031
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adagrasib, Pembrolizumab, Cetuximab, Pemetrexed.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Canada, China +15
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)
Overview
This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.
Interventions
- Drug Adagrasib
Specified dose on specified days - Drug Pembrolizumab
Specified dose on specified days - Drug Cetuximab
Specified dose on specified days - Drug Pemetrexed
Specified dose on specified days - Drug Docetaxel
Specified dose on specified days - Drug Irinotecan
Specified dose on specified days - Drug Leucovorin
Specified dose on specified days - Drug Oxaliplatin
Specified dose on specified days - Drug Fluorouracil
Specified dose on specified days
Primary outcome measures
- Number of Participants With Adverse Events (AEs) [Time frame: Up to 90 days from last dose or study discontinuation]
- Number of Participants With AEs Leading to Treatment Discontinuation [Time frame: Up to 90 days from last dose or study discontinuation]
- Number of Participants With Serious Adverse Events (SAEs) [Time frame: Up to 90 days from last dose or study discontinuation]
- Number of Participants With AEs Leading to Death [Time frame: Up to 90 days from last dose or study discontinuation]
Eligibility criteria
Inclusion criteria
- Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit.
- Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.
Exclusion criteria
- Participant is not eligible for study treatment per the parent study eligibility criteria.
- Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study.
- Participants not receiving clinical benefit from parent study drug as assessed by the investigator.
Other protocol defined inclusion/exclusion criteria applies.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 18 centers
- Local Institution - 0076 — Nice
- Local Institution - 0086 — Nice
- Local Institution - 0074 — Strasbourg
- Local Institution - 0103 — Pessac
- Local Institution - 0091 — Besançon
- Local Institution - 0065 — La Tronche
- Local Institution - 0063 — Saint-Herblain
- Local Institution - 0050 — Saint-Herblain
- … and 10 more centers
United States · 17 centers
- Local Institution - 0005 — Phoenix
- Southern California Permanente Medical Group — Bellflower
- Local Institution - 0082 — Long Beach
- Local Institution - 0003 — Newark
- Florida Cancer Specialists - North — St. Petersburg
- Local Institution - 0112 — Wichita
- Local Institution - 0092 — Boston
- Local Institution - 0080 — Boston
- … and 9 more centers
Spain · 15 centers
Center list to be confirmed — check the primary protocol.
China · 13 centers
- Local Institution - 0037 — Beijing
- Local Institution - 0045 — Xiamen
- Local Institution - 0042 — Zhengzhou
- Local Institution - 0038 — Changsha
- Local Institution - 0046 — Nanjing
- Local Institution - 0048 — Nanchang
- Local Institution - 0049 — Shenyang
- Local Institution - 0039 — Jinan
- … and 5 more centers
Italy · 10 centers
- Local Institution - 0019 — Rome
- Local Institution - 0053 — Bologna
- Local Institution - 0054 — Florence
- Local Institution - 0052 — Meldola
- Local Institution - 0021 — Milan
- Local Institution - 0107 — Milan
- Local Institution - 0020 — Orbassano
- Local Institution - 0079 — Pesaro
- … and 2 more centers
Netherlands · 4 centers
- Local Institution - 0056 — Breda
- Local Institution - 0034 — Amsterdam
- Local Institution - 0035 — Harderwijk
- Local Institution - 0071 — Utrecht
Greece · 3 centers
- Local Institution - 0081 — Athens
- Local Institution - 0022 — Attiki
- Local Institution - 0087 — Thessaloniki
Israel · 3 centers
- Local Institution - 0055 — Jerusalem
- Local Institution - 0119 — Haifa
- Local Institution - 0106 — Tel Aviv
South Korea · 3 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 3 centers
Center list to be confirmed — check the primary protocol.
Hungary · 2 centers
- Local Institution - 0089 — Budapest
- Local Institution - 0067 — Budapest
Poland · 2 centers
- Local Institution - 0102 — Gdansk
- Local Institution - 0101 — Lublin
Australia · 1 center
- Local Institution - 0093 — St Leonards
Belgium · 1 center
- Local Institution - 0033 — Ghent
Canada · 1 center
- Local Institution - 0072 — Vancouver
Germany · 1 center
- Local Institution - 0012 — München
Japan · 1 center
- Local Institution - 0110 — Tōon
Portugal · 1 center
- Local Institution - 0014 — Lisbon
Romania · 1 center
- Local Institution - 0060 — Craiova
Singapore · 1 center
- Local Institution - 0088 — Singapore
Identifiers
NCT: NCT07415031 · CA239-0071 · EU CTR · WHO