Trial reportJournal for immunotherapy of cancer2021
Randomized phase II trial of avelumab alone or in combination with cetuximab for patients with previously treated, locally advanced, or metastatic squamous cell anal carcinoma: the CARACAS study.
Trial report in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03944252 (Randomized Phase 2 Trial of Cetuximab and Avelumab or Avelumab Alone for Unresectable, Locally Advanced or Metastatic Squamous Cell Anal Carcinoma), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Phase 2 Trial of Cetuximab and Avelumab or Avelumab Alone for Unresectable, Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (SCCAC) Progressed After at Least One Line of Systemic Treatment
Who cites it
29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- Outcomes of Epidermal Growth Factor Receptor Inhibitors in Locally Advanced and Metastatic Anal Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis.Journal of gastrointestinal cancer · 2026Pooled it
- SEOM-GEMCAD-TTD clinical guidelines for anal cancer (2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Guideline
- Optimal early endpoint for second-line or subsequent immune checkpoint inhibitors in previously treated advanced solid cancers: a systematic review.BMC cancer · 2025Pooled it
- Phase II Trial of MEDI0457 and Durvalumab for Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers.The oncologist · 2023Trial
- Gut microbiota correlates with antitumor activity in patients with mCRC and NSCLC treated with cetuximab plus avelumab.International journal of cancer · 2022Trial
- Deciphering the Molecular Landscape of Squamous Cell Carcinoma of the Anal Canal: From Biology to Precision Oncology.Cancers · 2026Review
- Advances in anal cancer treatment: current standards, the role of immunotherapy and emerging strategies.ESMO gastrointestinal oncology · 2026Review
- Neoadjuvant and adjuvant chemotherapy in anal cancer - is there a role in the future?ESMO gastrointestinal oncology · 2026Article
- Real-world outcomes of pembrolizumab in advanced anal cancer: a nationwide Danish anal Cancer Group report.Acta oncologica (Stockholm, Sweden) · 2026Observational
- Efficacy of Immune Checkpoint Inhibitors and Oncoviruses in Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Review
- Review
- Review
- Clinicopathologic Features Associated with Survival for Immune Checkpoint Blockade in Patients with Metastatic Anal Cancer.Cancers · 2025Article
- Isolated hypoxic pelvic perfusion combined with electroporation is a valid alternative to traditional therapies for anal squamous cell carcinoma: a case study.Frontiers in oncology · 2025Article
- Evaluation of immune checkpoint inhibitors for colorectal cancer: A network meta‑analysis.Oncology letters · 2024Article
- Recent developments in immunotherapy for gastrointestinal tract cancers.Journal of hematology & oncology · 2024Review
- Immunological Checkpoint Blockade in Anal Squamous Cell Carcinoma: Dramatic Responses Tempered By Frequent Resistance.Current oncology reports · 2024Review
- Recent Advances in the Management of Anal Cancer.Healthcare (Basel, Switzerland) · 2023Review
- Hepatic Metastasectomy in Squamous Cell Carcinoma of the Anal Canal: A Case Series of a Curative Approach.Cancers · 2023Article
- Monoclonal antibodies for the treatment of squamous cell carcinoma: A literature review.Cancer reports (Hoboken, N.J.) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 18 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNo standard therapies beyond first line are established for advanced squamous cell anal carcinoma (aSCAC). Earlier preliminary data suggest activity of epidermal growth factor receptor (EGFR) inhibition and programmed cell death ligand (PD-(L))1 blockade in patients with previously treated disease. Aim of this study was to explore activity and safety of avelumab with/without cetuximab in patients with aSCAC.
methodsIn this open-label, non-comparative, 'pick the winner', multicenter randomized phase II trial (NCT03944252), patients with aSCAC progressing after one or more lines of treatment were randomized 1:1 to the anti-PD-L1 agent avelumab alone (arm A) or combined with cetuximab (arm B). Overall response rate (ORR) was the primary endpoint. With one-sided α error set at 0.05 and power of 80%, at least 4 responses out of 27 patients per arm had to be observed to declare the study positive. Secondary endpoints were progression free survival (PFS), overall survival (OS), and safety.
resultsThirty patients per arm were enrolled. Three patients in arm A and five in arm B achieved partial response: primary endpoint was reached in combination arm. ORR was 10% (95% CI 2.1 to 26.5) and 17% (95% CI 5.6 to 34.7) in arms A and B; disease control rate was 50% (95% CI 31.3 to 68.7) in arm A and 57 (95% CI 37.4-74.5) in arm B. At a median follow-up of 26.7 months (IQR 26.5-26.9), median PFS was 2.0 months (95% CI 1.8 to 4.0) in arm A and 3.9 (95% CI 2.1 to 5.6) in arm B. Median OS was 13.9 months (95% CI 7.7 to 19.4) in arm A and 7.8 (95% CI 6.2 to 11.2) in arm B. Acceptable safety profile was observed in both arms.
conclusionsCARACAS study met its primary endpoint in arm B, documenting promising activity of dual EGFR and PD-L1 blockade in aSCAC.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.