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Colon CancerPhase 2NCT05961709

The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer

A Phase 2 study testing Cemiplimab in people with Colon Cancer, run by M.D. Anderson Cancer Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To learn if cemiplimab can help to control dMMR colon cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer
What is being tested?
Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
5 sitesUnited States
Study dates
20 May 2024to 30 Apr 2028
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

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Age ≥18 years
  • Histological confirmation of colon adenocarcinoma, as determined by pathology review (inferior colon margin defined as >10 cm from anal verge).
  • Colon cancer that is deficient in mismatch repair (dMMR) or microsatellite Instability high (MSI-H) as determined by one of three methods:
  • Immunohistochemistry-determined dMMR by complete tumor nuclear loss of MLH1, PMS2, MSH2 or MSH6
  • PCR-determined MSI at >30% of tested microsatellites
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  • Next-generation-determined MSI-H based upon instability at multiple microsatellites as determined by the specific next generation sequencing panel
  • Localized colon cancer with (1) radiological staging of T3 or T4 or lymph node positive (stage II or III) OR (2) locally recurrent with luminal component OR (3) stage I with a surgical mortality defined as >5% by American College of Surgeons (ACS) National Surgery Quality Improvement Program
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Primary tumor that is deemed to be accessible by endoscopic intervention and willingness to undergo repeated endoscopic evaluations
  • Measurable or non-measurable disease by cross-sectional imaging per RECIST v1.1 criteria
  • Laboratory values (obtained within 7 days prior to registration) meeting the following criteria:
  • Absolute neutrophil count (ANC) ≥1000/mme
  • Platelet count >80,000/mm3
  • Hemoglobin >8 g/dL
  • Total bilirubin ≤1.5 x upper limit of normal (ULN) [for patients with Gilberts disease criteria is direct bilirubin ≤1.5 x ULN]
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3 x ULN
  • Creatinine <2.0 mg/dL
  • Negative urine or serum pregnancy test done ≤7 days prior to registration (women of childbearing potential only). NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • The effects of cemiplimab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 4 months after the last dose of cemiplimab. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.
  • Approved methods of birth control are as detailed in Appendix 4.
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of cemiplimab administration.
  • Willingness to return to enrolling institution for follow-up.
  • Willingness to provide mandatory blood specimens for correlative research (not applicable to external sites: Cancer Network sites and LBJ Hospital)
  • Ability to understand and the willingness to sign a written informed consent document.
  • Willing and able to comply with clinical trial instructions and requirements. Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 1 or 2 peripheral (sensory) neuropathy or alopecia
  • Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens; conditions including but not limited to:
  • symptomatic congestive heart failure
  • unstable angina pectoris
  • cardiac arrhythmia
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  • ongoing or active infection
  • psychiatric illness/social situations
  • dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
  • any other conditions that would limit compliance with study requirements
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy without undetectable viral load. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Receiving any other investigational agent, chemotherapy or other targeted therapy that would be considered as a treatment for the colon cancer.
  • Because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown, the following are not eligible for participation in this trial:
  • Pregnant persons
  • Nursing persons
  • Persons who are breastfeeding
  • Persons of childbearing potential who are unwilling to employ adequate contraception
  • Persons expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Any of the following prior therapies, if applicable:
  • Surgery ≤3 weeks prior to study treatment
  • Chemotherapy ≤2 weeks prior to study treatment
  • Radiation therapy ≤2 weeks prior to study treatment
  • Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) for colon cancer
  • Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Patient has known metastatic sites of disease. Note: locoregional lymph nodes or tumor deposits are not considered metastatic disease. Also, locally recurrent disease is allowed.
  • Patient has active autoimmune disease that has required systemic treatment in the past year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g.., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Cooper University Medical Center

    Camden, New Jersey, 08103

  • Banner - MD Anderson Cancer

    Gilbert, Arizona, 85234

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Ochsner

    New Orleans, Louisiana, 70121

Other trials in United States

About this study

To learn if cemiplimab can help to control dMMR colon cancer.

Read the detailed description

Primary Objective:

•To assess feasibility and success of an organ-sparing strategy in patients with localized dMMR colorectal cancer receiving neoadjuvant cemiplimab. The primary endpoint is rate of endoCR by 6 months.

Exploratory Objectives:

  • To quantify organ-sparing rate at 1 year for all patients treated with one dose of cemiplimab (intent to treat)
  • To quantify the composite rate of either non-operative management at 1 year or pathological complete response for all patients treated with one dose of cemiplimab (intent to treat)
  • To quantify the composite rate of either endoCR by 6 months or pathologic complete response for all patients treated with one dose of cemiplimab (intent to treat)
  • To assess and describe features observed on endoscopy after neoadjuvant cemiplimab
  • To assess radiographic response to neoadjuvant cemiplimab
  • To estimate the relapse-free survival, progression-free survival and overall survival in all enrolled participants
  • To determine the overall rates of pathological response to neoadjuvant cemiplimab in patients who undergo resection after receiving at least one dose of cemiplimab
  • To determine overall safety of cemiplimab for patients with localized colon cancer
  • To determine the change in patient-reported symptoms with cemiplimab
  • To explore the predictive ability of changes in ctDNA for efficacy endpoints
  • To determine if total mutational burden and genomic alterations correlate with response and extent of benefit from cemiplimab
  • To correlate tumor-immune microenvironment (for example T-effector cell populations; CD4 subsets; T-regulatory populations; B cell populations; dendritic and macrophage populations) in pre-treatment tumor samples with efficacy endpoints
  • To compare targeted gene expression profiles of immune-related genes and genes pertaining to common cancer signaling pathways in pre-treatment samples as well as the change in these factors (for cases with both pre-treatment and on-treatment tumor samples) between responders and non-responders
Conditions
Colon Cancer
Being tested
Cemiplimab
Medical subject headings
Colonic Neoplasms

What participants receive

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

Study groups in NCT05961709
Study groupRoleWhat they receive
CemiplimabExperimentalParticipants will receive cemiplimab by vein over about 30 minutes on Day 1 of each 3-week study cycle, up to 8 cycles.
Receives: Drug: Cemiplimab

What is being measured

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

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year

Timeline

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

  1. First posted27 Jul 2023
  2. Study start20 May 2024
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05961709
Sponsor's protocol ID
2023-0228
Other IDs
NCI-2023-05749
Status last verified
Oct 2026
First submitted
18 Jul 2023
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cemiplimab in people with Colon Cancer, run by M.D. Anderson Cancer Center at 5 sites 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 30 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: Through study completion; an average of 1 year). 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 NCT05961709.

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 13 Oct 2026.

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