Trial · NCT03475953
A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors
NCT03475953, Phase 1, Phase 2, Unknown, Institut Bergonié
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors. Trials, record NCT03475953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03475953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors
- NCT number
- NCT03475953
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 747 participants, estimated
- Lead sponsor
- Institut Bergonié
- Conditions
Colorectal Cancer Not MSI-H or MMR-deficient, GIST, Oesophageal or Gastric Carcinoma, Biliary Tract Cancer, Hepatocellular Carcinoma, Soft-tissue Sarcoma, Thyroid Cancer, Gastro-enteropancreatic Neuroendocrine Tumor, Non-small Cell Lung Cancer, Solid Tumor, Adult, Urothelial Carcinoma, HPV-Related Carcinoma, Triple Negative Breast Cancer, Renal Carcinoma, Mesotheliomas Pleural
- Interventions
- Phase 1 : Regorafenib, Phase 1 : Avelumab, Phase 2 : Regorafenib, Phase 2 : Avelumab, Phase 2: low-dose Regorafenib
- First posted
- 2018-03-23
- Last updated
- 2023-03-03
- Other registries' IDs
- eudract:2016-005175-27
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PHASE I : Recommended phase II dose (RP2D) | During the first cycle (28 days) | Recommended phase II dose (RP2D) evaluated on the first cycle (Day 1 to Day 28) of regorafenib when prescribed in association with avelumab. |
| Primary | PHASE II (7cohorts A, C, D, E, F and G) : Assessment of the antitumor activity of regorafenib | Throughout the treatment period, an average of 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab based on objective response under treatment defined as CR or PR following RECIST v1.1 criteria. |
| Primary | Phase II (cohorts B, H, I, M, N, O and P): Assessment of the antitumor activity of regorafenib | 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab based on 6-month progression-free rate, defined as CR, PR and SD following RECIST v1.1 criteria. |
| Primary | Phase II (cohort A'): Assessment of the antitumor activity of regorafenib | 4 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab based on 4-months progression-free rate, defined as CR, PR and SD following RECIST v1.1 criteria. |
| Secondary | PHASE I : Maximum Tolerated Dose (MTD) | During the first cycle (28 days) | Maximum Tolerated Dose (MTD) evaluated on the first cycle (Day 1 to Day 28) of regorafenib when prescribed in association with avelumab. |
| Secondary | PHASE I : Dose Limiting Toxicities (DLT) | During the first cycle (28 days) | Dose Limiting Toxicities (DLT) evaluated on the first cycle (Day 1 to Day 28) of regorafenib when prescribed in association with avelumab. |
| Secondary | PHASE I : Toxicity | Throughout the treatment period, an average of 6 months | Toxicity graded using the common toxicity criteria from the NCI v5. |
| Secondary | PHASE I : Assessment of the antitumor activity of regorafenib - Best overall response | Throughout the treatment period, an average of 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab in terms of best overall response as per RECIST v1.1. |
| Secondary | PHASE I :Assessment of the antitumor activity of regorafenib - objective response rate under treatment | Throughout the treatment period, an average of 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab in terms of objective response rate under treatment (ORR) defined as CR or PR as per RECIST v1.1. |
| Secondary | PHASE I :Assessment of the antitumor activity of regorafenib - objective response rate | Throughout the treatment period, an average of 6 months | Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab in terms of objective response rate at 6-months (ORR) defined as CR or PR as per RECIST v1.1. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03475953
GET https://conductscience.org/api/trials/v1/NCT03475953/registered?page=2