Recruiting nowPhase 2Randomised
| Registry number | NCT07281768 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 66 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Oxaliplatin
- Drug Capecitabine
- Drug Cemiplimab
- Drug Fianlimab
- Drug REGN7075
What it is measuring
Pathologic complete response (pCR) rate
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers are testing whether adding the immune treatment cemiplimab, alone or with fianlimab (which blocks another immune checkpoint, LAG-3) or REGN7075 (which is designed to bring T cells into contact with CEA-bearing cancer cells), to CAPOX chemotherapy before surgery can make locally advanced, microsatellite-stable (MSS) rectal tumours more likely to disappear on examination. The trial compares these treatment combinations in people with selected stage II–III rectal cancer.
The idea is that chemotherapy may damage tumour cells while the added immune treatments help the immune system recognise and attack what remains. The main measure is the rate of pathological complete response—no cancer found in the tissue removed at surgery—along with safety and clinical activity, rather than survival or time before the cancer grows.
Worth knowing: This is a small phase 2 trial with no usual-treatment control group, and pathological complete response is an early measure rather than proof of longer survival or avoiding surgery.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab/fianlimab, or cemiplimab/REGN7075 with capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with microsatellite stable (MSS) locally advanced rectal cancer (T2 node-positive, T3 node-negative, T3 node-positive).
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 – 1.
- Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound.
- Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma.
- Must not have received any prior systemic treatment or radiation.
- Candidate for sphincter-sparing surgical resection after neoadjuvant therapy according to the primary surgeon.
- Patients have the following clinical staging:
- cT2 node-positive:
- T: Tumor is invading the muscularis propria but has not grown through it to the serosa
- N: At least 1 perirectal lymph node ≥5 mm and no more than 4 perirectal lymph nodes >10 mm in short axis
- M: No evidence of metastasis
- cT3 node-negative
- T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs
- N: No perirectal lymph nodes ≥ 5 mm in size that suggest tumor involvement
- M: No evidence of metastasis
- cT3 node-positive
- T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs
- N: At least 1 perirectal lymph node ≥ 5 mm and no more than 4 perirectal lymph nodes > 10 mm in size in short axis
- M: No evidence of metastasis
- Absence of distant metastases on CT or…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07281768, registered by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.