UnknownPhase 1/2

A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

France747 participantsStarted 2018-05-04

Plain-language summary

Assessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial). Assessement of the efficacy and safety of a low-dose of regorafenib (80mg/day) with avelumab in patients with advanced or metastatic colorectal tumors.

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

. Histology:
. Advanced non resectable / metastatic disease,
. Patients for which either there is no further established therapy that is known to provide clinical benefit, OR (for patients to be treated with 160 mg regorafenib) regorafenib monotherapy is an approved or established therapeutic option,
. Age ≥ 18 years,
. ECOG, Performance status ≤ 1,
. Measurable disease according to RECIST,
. Life expectancy \> 3 months,
. Except for cohorts F and H, ≥ 1 previous line (s) of systemic therapy,

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

PHASE I : Recommended phase II dose (RP2D)

Timeframe: During the first cycle (28 days)

PHASE II (7cohorts A, C, D, E, F and G) : Assessment of the antitumor activity of regorafenib

Timeframe: Throughout the treatment period, an average of 6 months

Phase II (cohorts B, H, I, M, N, O and P): Assessment of the antitumor activity of regorafenib

Timeframe: 6 months

Phase II (cohort A'): Assessment of the antitumor activity of regorafenib

Timeframe: 4 months

Trial details

NCT IDNCT03475953

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Sophie COUSIN, MD

+33 5.56.33.33.33 s.cousin@bordeaux.unicancer.fr

View on ClinicalTrials.gov More Colorectal Cancer Not MSI-H or MMR-deficient trials

Plain-language summary

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

. Histology:
. Advanced non resectable / metastatic disease,
. Patients for which either there is no further established therapy that is known to provide clinical benefit, OR (for patients to be treated with 160 mg regorafenib) regorafenib monotherapy is an approved or established therapeutic option,
. Age ≥ 18 years,
. ECOG, Performance status ≤ 1,
. Measurable disease according to RECIST,
. Life expectancy \> 3 months,
. Except for cohorts F and H, ≥ 1 previous line (s) of systemic therapy,

What they're measuring

PHASE I : Recommended phase II dose (RP2D)

Timeframe: During the first cycle (28 days)

PHASE II (7cohorts A, C, D, E, F and G) : Assessment of the antitumor activity of regorafenib

Timeframe: Throughout the treatment period, an average of 6 months

Phase II (cohorts B, H, I, M, N, O and P): Assessment of the antitumor activity of regorafenib

Timeframe: 6 months

Phase II (cohort A'): Assessment of the antitumor activity of regorafenib

Timeframe: 4 months

A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria