AzTrials
AzTrials

Colorectal CancerPhase 2NCT07281768

Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer

A Phase 2 study testing Oxaliplatin, Capecitabine and Cemiplimab in people with Colorectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Oxaliplatin, Capecitabine and Cemiplimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
14 Jul 2026to Jul 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 24Show fewer
  • 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 MRI imaging
  • Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
  • LVEF assessment with documented LVEF ≥ 50% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.
  • For both Women and Men, must use acceptable form of birth control while on study.
  • Ability to understand and willingness to sign a written informed consent document.

Who cannot join

  • Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
  • Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
  • Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
  • History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason.
  • Currently using any chronic systemic steroids.
  • History of severe hypersensitivity reaction to any monoclonal antibody.
Show all 23Show fewer
  • History of encephalitis, meningitis, dementia, Parkinson's or uncontrolled seizures within 1 year prior to the first dose of study drug.
  • Uncontrolled infection of HIV, HBV, HCV, or Tuberculosis.
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Active autoimmune disease.
  • Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
  • Patient has a pulse oximetry of <92% on room air.
  • Patient is on supplemental home oxygen.
  • Has clinically significant heart disease.
  • Troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline.
  • Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
  • Patient is pregnant or breastfeeding.
  • Unwilling or unable to follow the study schedule for any reason.
  • Patient received a live vaccine within 30 days of planned start of study medication.
  • Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.
  • Patients with T4 disease or N2 disease (as defined by >/= 4 lymph nodes, each greater or equal to 10 mm in short axis).
  • Evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or endorectal ultrasound or pelvic CT scan.
  • Patients with symptomatic untreated bowel obstruction due to rectal cancer.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Colleen Apostol, RN contact

410-614-3644

GIClinicalTrials@jhmi.edu

United States1 site, 1 recruiting

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

    Colleen Apostol, RN, 410-614-3644, GIClinicalTrials@jhmi.edu

    Eric Christenson, MD

    Recruiting

Other trials in United States

About this study

Official title: Combining Capecitabine/Oxaliplatin Chemotherapy With Cemiplimab Alone or in Combination With Fianlimab or REGN7075 for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

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).

Being tested
Oxaliplatin, Capecitabine, Cemiplimab, Fianlimab, REGN7075
Keywords
Rectal Cancer, Cemiplimab, Fianlimab, REGEN7075, Oxaliplatin, Capecitabine, Immunotherapy, Anti-PD-1 (Programmed Death-Ligand 1)(protein immune checkpoint), PD-L1 (Programmed Death-Ligand 1)(protein immune checkpoint), Adenocarcinoma, Carcinoma, CAPOX, Chemotherapy
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms, Adenocarcinoma, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Patients will receive Oxaliplatin (130mg/m^2 administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

  • CapecitabineDrug

    Also called Xeloda

    Patients will receive Capecitabine (1000mg/m^2 administered orally) on Days 1 through 14 of each 21 day cycle for a total of 4 cycles of treatment.

  • CemiplimabDrug

    Also called REGN2810, LIBTAYO

    Patients will receive Cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

  • FianlimabDrug

    Also called REGN3767

    Patients will receive Fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

  • REGN7075Drug

    Patients will receive REGN7075 (2700 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Study groups in NCT07281768
Study groupRoleWhat they receive
Arm A (Oxaliplatin, Capecitabine, Cemiplimab)ExperimentalNot described
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Cemiplimab
Arm B (Oxaliplatin, Capecitabine, Cemiplimab, Fianlimab)ExperimentalNot described
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Cemiplimab; Drug: Fianlimab
Arm C (Oxaliplatin, Capecitabine, Cemiplimab, REGN7075)ExperimentalNot described
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Cemiplimab; Drug: REGN7075

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic complete response (pCR) rate

    Proportion of subjects with a pathologic complete response (pCR) at the time of surgery. pCR is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen using the College of American Pathologists (CAP) tumor regression scoring system (CAP tumor regression score of 0).

    Measured: 24 months

Secondary outcomes (4)

  1. Number of participants experiencing grade 3 or above drug-related toxicities

    When calculating the incidence of Adverse Events (AEs), each AE (as defined by NCI CTCAE v6.0) will be counted only once for a given subject.

    Measured: 12 weeks

  2. Pathologic Response Rate

    Pathologic response rate as defined as the proportion of subjects with complete or partial tumor regression at the time of surgery using the College of American Pathologists (CAP) tumor regression scoring system (CAP tumor regression score of 0 to 2).

    Measured: 24 months

  3. Event-free Survival (EFS)

    EFS is defined as the number of months from the date of initiation of neoadjuvant treatment to disease relapse or development of metastatic disease (as assessed using RECIST 1.1 criteria) or death due to any cause. EFS will be censored at the date of the last scan for subjects without documentation of disease progression at the time of analysis.

    Measured: 24 months

  4. Composite Complete Response Rate

    Composite complete response rate is defined as the proportion of subjects with either a pathologic complete response (pCR) or those that remain disease-free for 24 months on radiographic imaging and endoscopic evaluation for those that elected to not go to surgery. pCR is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen using the College of American Pathologists (CAP) tumor regression scoring system (CAP tumor regression score of 0).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start14 Jul 2026
  3. Primary completionJul 2030 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07281768
Sponsor's protocol ID
J25118
Other IDs
IRB00505702
Status last verified
Jul 2026
First submitted
4 Dec 2025
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, Capecitabine and Cemiplimab in people with Colorectal Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Colleen Apostol, RN (410-614-3644, GIClinicalTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response (pCR) rate (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07281768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in