LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectabl… (NCT04616183) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer
United States46 participantsStarted 2020-12-02
Plain-language summary
This phase Ib/II trial investigates the side effects and best dose of LY3214996 when given together with cetuximab alone or in combination with abemaciclib and to see how well they work in treating patients with colorectal cancer that cannot be removed by surgery (unresectable) and/or has spread to other places in the body (metastatic). Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. LY3214996 and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving LY3214996 and cetuximab alone or in combination with abemaciclib may help treat patients with colorectal cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of signed Informed Consent prior to any screening procedures being performed. The informed consent process will be conducted in accordance with MD Anderson Office of Clinical Research SOP 04 and as indicated in Appendix 2.
* Age ≥18 years at the time of informed consent.
* Histologically (or cytologically) confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or metastatic disease that is measureable according to RECIST1.1 criteria.
* Baseline tissue-based KRAS, NRAS, EGFR, BRAF wild-type tumor. If MEK1 was tested, must be wild-type tumor
* Prior treatment with at least one systemic chemotherapy regimen for mCRC, or recurrence/progression with development of unresectable or metastatic disease within 6 months of adjuvant chemotherapy for resected colorectal cancer.
* Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade .1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the participant did not receive radiotherapy).
* Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization
* Left-sided…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is combining LY3214996 — an ERK inhibitor I'm not familiar with — with cetuximab, and sometimes also adding abemaciclib, which is usually used in breast cancer; can you explain why this combination makes sense for my specific type of colorectal cancer and whether my tumor's molecular profile fits what they're looking for?
2Since this is a Phase 1/2 trial, the researchers are still working out safety and dosing alongside early signs of effectiveness — what does that mean for the balance of risk versus potential benefit in my situation compared to standard treatment options I haven't tried yet?
3The trial is listed as active but no longer recruiting new patients — does that mean this option is completely off the table for me, or are there related trials or expanded access programs using these same drugs that might still be open?
4The primary goal they're measuring is best overall response, meaning tumor shrinkage — how does that compare to what standard therapies might realistically achieve for my stage of colorectal cancer right now?
5What side effects should I be aware of from combining an ERK inhibitor like LY3214996 with cetuximab — and potentially abemaciclib on top of that — and how might managing those affect my day-to-day life during treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Best overall response (complete response [CR] + partial response [PR])
Timeframe: From the start of the treatment until disease progression, assessed up to 1 year