A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors (NCT03475953) | Clinical Trial Compass
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 range18 Years
SexALL
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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,
Exclusion criteria
✕. Previous treatment with Avelumab or Regorafenib,
✕. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways), except for cohort H (NSCLC), Cohort I (Solid tumors (including Soft Tissue Sarcoma) with immune signature (TLS+)) and cohort P (malignant pleural mesothelioma),
✕. Evidence of progressive or symptomatic or newly diagnosed central nervous system (CNS) or leptomeningeal metastases,
✕. Men or women of childbearing potential who are not using an effective method of contraception as previously described;
What they're measuring
1
PHASE I : Recommended phase II dose (RP2D)
Timeframe: During the first cycle (28 days)
2
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
3
Phase II (cohorts B, H, I, M, N, O and P): Assessment of the antitumor activity of regorafenib
Timeframe: 6 months
4
Phase II (cohort A'): Assessment of the antitumor activity of regorafenib