NCT04561336

Avelumab Plus Cetuximab in Pre-treated RAS Wild Type Metastatic Colorectal Cancer

Completed Phase 2 Last updated 5 May 2022

What this trial tests

Phase 2 trial testing Avelumab in Metastatic Colorectal Cancer in 77 participants. Completed in 14 November 2021.

Timeline

10 August 2018

Primary endpoint
14 November 2021

14 November 2021

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	77
Start date	10 August 2018
Primary completion	14 November 2021
Estimated completion	14 November 2021
Sites	1 location across Italy

Drugs / interventions tested

• Avelumab (avelumab) — full drug profile →
• Cetuximab (cetuximab) — full drug profile →

Conditions studied

• Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
• RAS Wild Type — all drugs for RAS Wild Type →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

18 and older, any sex, with Metastatic Colorectal Cancer or RAS Wild Type. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a non-profit phase II, open-label, single-arm study of cetuximab plus avelumab in patients with RAS WT mCRC treated in first line with chemotherapy in combination with an anti- EGFR drug that have had a clinical benefit (complete or partial response) from treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cetuximab Rechallenge Plus Avelumab in Pretreated Patients With RAS Wild-type Metastatic Colorectal Cancer: The Phase 2 Single-Arm Clinical CAVE Trial.
   Martinelli E, Martini G, Famiglietti V, Troiani T, et al · · 2021 · cited 128× · PMID 34382998 · DOI 10.1001/jamaoncol.2021.2915
2. Predictive biomarkers of colon cancer immunotherapy: Present and future.
   Hou W, Yi C, Zhu H. · · 2022 · cited 100× · PMID 36483562 · DOI 10.3389/fimmu.2022.1032314
3. Combination Strategies to Augment Immune Check Point Inhibitors Efficacy - Implications for Translational Research.
   Varayathu H, Sarathy V, Thomas BE, Mufti SS, et al · · 2021 · cited 62× · PMID 34123767 · DOI 10.3389/fonc.2021.559161
4. Gut microbiota correlates with antitumor activity in patients with mCRC and NSCLC treated with cetuximab plus avelumab.
   Martini G, Ciardiello D, Dallio M, Famiglietti V, et al · · 2022 · cited 57× · PMID 35429341 · DOI 10.1002/ijc.34033
5. The Right Partner in Crime: Unlocking the Potential of the Anti-EGFR Antibody Cetuximab <i>via</i> Combination With Natural Killer Cell Chartering Immunotherapeutic Strategies.
   Baysal H, De Pauw I, Zaryouh H, Peeters M, et al · · 2021 · cited 41× · PMID 34557197 · DOI 10.3389/fimmu.2021.737311
6. Advances in immune checkpoint inhibitor combination strategies for microsatellite stable colorectal cancer.
   Ros J, Balconi F, Baraibar I, Saoudi Gonzalez N, et al · · 2023 · cited 33× · PMID 36816981 · DOI 10.3389/fonc.2023.1112276
7. Anti-EGFR Rechallenge in Patients With Refractory ctDNA RAS/BRAF wt Metastatic Colorectal Cancer: A Nonrandomized Controlled Trial.
   Ciardiello D, Martinelli E, Troiani T, Mauri G, et al · · 2024 · cited 32× · PMID 38592721 · DOI 10.1001/jamanetworkopen.2024.5635
8. Progress in the Application of Immune Checkpoint Inhibitor-Based Immunotherapy for Targeting Different Types of Colorectal Cancer.
   He R, Lao Y, Yu W, Zhang X, et al · · 2021 · cited 31× · PMID 34888243 · DOI 10.3389/fonc.2021.764618