Colon CancerPhase 2PREMICESNCT06646445
Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study.
A Phase 2 study testing Pembrolizumab Injection [Keytruda], Watch-and-wait approach and Surgery in people with Colon Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 10 sites in France.
Trial summary
The goal of this investigational, multicenter, open-label randomized, two-stage phase II study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach in patients with localized deficient mismatch repair / high microsatellite instability (dMMR/MSI-H) colorectal cancer (CRC). 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?
- Pembrolizumab Injection [Keytruda], Watch-and-wait approach and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesFrance
- Study dates
- Sep 2025to Dec 2029
- 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
- Signed and dated informed consent (IC),
- Aged ≥18 years,
- An Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1,
- Newly diagnosed, histologically confirmed colonic or upper third rectal adenocarcinoma, NB: material must be available from biopsy done during colonoscopy.
- Radiological tumor assessment at screening performed within 21 days before inclusion according to RECIST v1.1 by chest, abdomen, and pelvis (TAP- CT) showing resectable localized disease (cT0-4 cN0-2 cM0) and no metastatic disease,
- dMMR and/or MSI-high (MSI-H) tumor status as follows:
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- loss of expression of ≥1 MMR protein (MLH1, MSH2, MSH6, or PMS2) or a dimeric couple (MLH1 and PMS2 or MSH2 and MSH6) on immunohistochemistry (IHC; using hMLH1, hMSH2, hMSH6, hPMS2 antibodies),
- And/or ≥ 3 instable markers by the pentaplex by polymerase chain reaction (PCR) (BAT-25, BAT-26, NR-21, NR-24, and NR-27),
- NB:
- In case of two instable markers by PCR, it is required to present confirmation of the dMMR status by IHC or comparison of PCR test with matched normal tissue.
- In case of loss of expression of only one MMR protein by IHC or any other IHC pattern, it is required to confirm MSI status using pentaplex PCR; Agreement of Sponsor on a dMMR/MSI status is mandatory to include the patient (the patient's file [an anonymized mail] must be send to Sponsor before inclusion). Approval/refusal email for inclusion of the patient will be sent by Sponsor within 24 hours of receipt of the Investigator email. In case of discrepancy between IHC and PCR, the final decision about the dMMR/MSI status will be taken by Sponsor or coordinating investigator,
- Adequate hematological status, renal, and liver function obtained within 14 days prior to randomization of study treatment:
- absolute neutrophil count (ANC) ≥1.5 x 10^9/L; platelets ≥100 x 10^9/L; hemoglobin ≥9 g/dL,
- serum creatinine level <150 µM or clearance >50 ml/min (Modification of the Diet in Renal Disease [MDRD] or Cockcroft and Gault),
- serum bilirubin ≤1.5 × upper limit of normal (ULN), alkaline phosphatase <5 x ULN, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 x ULN,
- International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5 × ULN, except for the patient on anticoagulant therapy who must have PT-INR-aPTT within therapeutic range is deemed appropriate by the Investigator,
- Has no contraindications to administration of oxaliplatin, capecitabine, or 5-fluorouracil, according to their respective summaries of product characteristics (SmPCs),
- Is able to undergo surgery and receive adjuvant treatment (chemotherapy) as part of standard care,
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a woman of non-childbearing potential as defined: i/ ≥45 years of age and has not had menses for >1 year, ii/ amenorrhea for <2 years without a hysterectomy and oophorectomy and have a high follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-study (screening) evaluation, iii/ post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan,
- Negative pregnancy blood test within 72 hours before the first dose of pembrolizumab, AND
- If woman of childbearing potential (WOCBP), female patient must be willing to use a highly effective form of contraception (Appendix 24.9) from screening throughout the study treatment and 4 months after the last dose of pembrolizumab,
- Male patient is eligible to participate if he agrees to the following during the study treatment and for 4 months after the last dose of pembrolizumab:
- Refrain from donating sperm,
- Must use contraception/barrier as follows:
- Agree to use a male condom when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
- Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person,
- Primary tumor tissue samples (archival or fresh biopsy specimen) acquired during coloscopy together with images availability (mandatory), NB: The patient's agreement will be specifically requested for endoscopic images in the patient information note and informed consent for their use as clinical data that may be analyzed and presented in publications. These data will be used in the same manner as other personal data. The confidentiality of these data will be maintained,
- Patient willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study,
- Registeration in the National Health Care System (PUMa - Protection Universelle Maladie included).
Who cannot join
- Tumor that is not readily resectable,
- Bifocal colorectal adenocarcinoma,
- Locally advanced middle or low rectal cancer (<10 cm from the anal verge on MRI, sagittal slide) staged as cT3/T4 and/or N+ and/or with predictive circumferential margin >2 mm on pretreatment MRI, NB: for rectal cancers, the margin of the tumor relative to the anal margin should be indicated on the endoscopy report,
- Major surgical procedure within 4 weeks prior to the first dose of study treatment,
- Pre-existing hemostatic disorder or medical condition requiring chronic anticoagulation that cannot be interrupted for the purpose of study specified tumor resection or endoscopic biopsies,
- Metastases (stage IV disease),
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- Has history of uncontrolled or symptomatic cardiac disease,
- Prior treatment with an anti-PD(L)1, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents,
- Prior malignancy active within the previous 3 years apart from: i/ locally curable cancers that have been apparently cured (e.g., squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast); ii/ Lynch syndrome-related non-CRC in complete remission for > 1 year,
- Patient is human immunodeficiency virus (HIV)-positive with CD4+ cell count <600 cell/ml or detectable viral load,
- Has complete or partial dihydropyrimidine dehydrogenase deficiency (uracilemia ≥16 ng/ml), In particular, the uracilemia level must be determined before patient inclusion. Patients with altered uracilemia will be excluded.
- Patient has active hepatitis B virus (HBV, defined as having a positive hepatitis B surface antigen [HBsAg] test) or hepatitis C virus (HCV) prior to inclusion, NB: Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen antibody test) are eligible. NB: Patients positive for HCV antibody are eligible only if PCR testing is negative for HCV RNA.
- Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness.
- Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent,
- Non-eligible to immunotherapy:
- Any history of autoimmune disease including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, NB: History of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
- NB: Controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
- Prior (non-infectious) pneumonitis requiring systemic corticosteroid therapy or has currently pneumonitis,
- Any live, attenuated vaccine within 30 days prior to the first dose of study treatment or such administration is anticipated during the study,
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 14 days (2 weeks) prior to the first dose of trial treatment or is required to receive systemic immunosuppressive medications during the study. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Ongoing anti-cancer treatment for another cancer (to be discussed with the coordinator in case of hormone therapy in patients with prostate and breast cancer),
- Known hypersensitivity to any of the excipients of pembrolizumab, NB: L-histidine, L-Histidine Hydrochloride monohydrate, sucrose, polysorbate-80 (E433).
- NB: L-histidine, L-Histidine Hydrochloride monohydrate, sucrose, polysorbate-80 (E433).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites
Institut Sainte Catherine
Avignon
Clémence TOULLEC, 0490275760, c.toullec@isc84.org
Clémence TOULLEC
CHU Besançon
Besançon
Angélique VIENOT, 0370632403, a3vienot@chu-besancon.fr
Angélique VIENOT
IHFB Cognacq Jay
Levallois-Perret
Benoist CHIBAUDEL, 0147595965, benoist.chibaudel@ihfb.org
Benoist CHIBAUDEL
Centre Leon Berard
Lyon
Aurélien DUPRE, 0478782933, aurelien.dupre@lyon.unicancer.fr
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris
Olivier DUBREUIL, 0144742839, odubreuil@hopital-dcss.org
Olivier DUBREUIL
Hôpital Saint Antoine
Paris
Romain COHEN, 0149282336, romain.cohen@aphp.fr
Romain Cohen
Institut Mutualiste Montsouris
Paris
Raphael COLLE, 0156616241, raphael.colle@imm.fr
Raphaël COLLE
CHU Bordeaux Haut Lévêque
Pessac
Eric TERREBONNE, 0557656439, eric.terrebonne@chu-bordeaux.fr
Eric TERREBONNE
CHU Poitiers
Poitiers
David TOUGERON, 0549444886, david.tougeron@chu-poitiers.fr
CHU Toulouse
Toulouse
Rosine GUIMBAUD, 0561322142, guimbaud.r@chu-toulouse.fr
Rosine GUIMBAUD
About this study
Official title: Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for Patients With Mismatch Repair-deficient or Microsatellite Instability-high (dMMR/MSI-H) Localized Colon Cancer: a Randomized GERCOR G-109 PRODIGE 84 PREMICES Phase II Trial
The goal of this investigational, multicenter, open-label randomized, two-stage phase II study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach in patients with localized deficient mismatch repair / high microsatellite instability (dMMR/MSI-H) colorectal cancer (CRC). The PREMICES trial is based on the hypothesis that non-operative management is effective for dMMR/MSI-H localized CRC when treated with neoadjuvant pembrolizumab.
Eligible patients will be randomized in a 1:1 ratio to receive either pembrolizumab with a watch-and-wait approach (experimental arm A) or the standard strategy of surgical resection ± adjuvant chemotherapy (arm B).
Read the detailed description
dMMR/MSI-H is a key biomarker for predicting the success of immune checkpoint inhibitors in colorectal cancer (CRC). Pembrolizumab has shown improved outcomes for patients with metastatic CRC, becoming the new standard of care. Neoadjuvant immunotherapy has demonstrated high rates of complete pathological responses in both metastatic and localized CRC, with promising results in non-surgical approaches. Studies support using a "watch-and-wait" strategy after immunotherapy, potentially avoiding surgery. These findings are reshaping treatment strategies for dMMR/MSI-H CRC, particularly regarding organ preservation and non-operative management.
The PREMICES study evaluates the efficacy of neoadjuvant pembrolizumab combined with a watch-and-wait approach for treating localized dMMR/MSI-H CRC. It investigates non-operative management as a potential strategy for achieving a complete clinical response in dMMR/MSI-H localized CRC without the need for surgery.
- Conditions
- Colon Cancer
- Being tested
- Pembrolizumab Injection [Keytruda], Watch-and-wait approach, Surgery, Adjuvant chemotherapy
- Keywords
- pembrolizumab, watch-and-wait, microsatellite instability, mismatch repair deficient
- Medical subject headings
- Colonic Neoplasms, Microsatellite Instability, Turcot syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab Injection [Keytruda]Drug
Also called Keytruda
Pembrolizumab 200 mg via a 30-minute IV infusion q3w on Day 1 of each 21-day cycle; 8 cycles ± 9 additional cycles (17 cycles in total).
Watch-and-wait approachProcedure or surgery
Watch-and-wait strategy:
- TAP-CT scan At months 3 and 6 during 8 cycles of treatment, at months 9 and 12, and during additional 9 cycles of treatment if performed, and every 3 months thereafter for up to 2 years,
- Colonoscopy with biopsies at months 3, 6, 9, 12, and 24.
SurgeryProcedure or surgery
Standard of care surgery performed with a maximal delay of 21 days (3 weeks) from randomization.
Adjuvant chemotherapyDrug
Adjuvant chemotherapy (5-fluorouracil/capecitabine ± oxaliplatin 3 months to 6 months) according to the current guidelines, at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm A (Pembrolizumab plus watch-and-wait approach) | Experimental | Pembrolizumab and Watch-and-wait (TAP-CT scan, colonoscopy with biopsies) Receives: Drug: Pembrolizumab Injection [Keytruda]; Procedure: Watch-and-wait approach |
| Arm B (Surgical resection ± adjuvant chemotherapy) | Active comparator | Standard of care surgery ± adjuvant chemotherapy (5-fluorouracil/capecitabine ± oxaliplatin 3 months to 6 months) Receives: Procedure: Surgery; Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of success of the experimental strategy at 6 months or after two successive colonoscopies (corresponding to timepoint at 6 months from the experimental strategy) following randomization.
The success at 6 months is defined as an absence of death, of disease progression, or of decision to perform surgery of the primary tumor for residual cells on biopsies, or for any other reason.
Measured: 6 months
Secondary outcomes (8)
The rate of strategy success at 24 months
The rate of strategy success at 24 months after randomization in the experimental arm
Measured: 24 months
Incidence of Adverse Events (Safety assessment)
Safety (according to NCI CTCAE v 5.0) of experimental strategy
Measured: Up to 4 years
Overall surival (OS) at 6, 12 and 24 months in both study arms
OS is defined as the time between the date of randomization and the date of death from any cause. Survival data will be censored at the last follow-up.
Measured: Up to 24 months
Event-free survival (EFS) at 6, 12 and 24 months in both study arms
EFS defined as the time from randomization to the first of the following events:
- In experimental arm: death of all causes, PD, second primary CRC; decision to perform surgery of the primary tumor for residual cells on biopsies, or for any other reason.
- In arm B: death of all causes, second primary CRC, local or metastatic relapse, whichever occurred first.
Measured: Up to 24 months
30-day and 90-day postoperative morbidity for patients who underwent surgery in both study arms
Postoperative morbidity is defined as a complication occurring during the hospital stay or within 30 or 90 days after surgery. Postoperative complications will be documented in a standardized form and their severity.
Measured: Up to 90 days post-surgery
Time to deterioration (TTD) of health-related quality of life (HRQoL)
TTD of HRQoL will be used to longitudinally analyze all HRQoL data (integrating all HRQoL measures). It is defined as the time interval between randomization in the study to the observation of a first deterioration of at least 10 points minimal clinically important difference (MCID) as compared to the baseline score. Meassurements at baseline, treatment visits, evaluation visits, end of treatment visit, and follow-up in both study arms.
Measured: Up to 4 years
Endoscopic complete response (ecR) assessment
Endoscopy, accompanied by tissue biopsy, will be performed at months 3, 6, 9, 12, and 24 as a part of the watch-and-wait approach in the experimental arm. Endoscopy with biopsy of potential macroscopic lesions will be performed at 12 months in the arm B, as part of the standard of care.
Endoscopic tumor response will be categorized as follows: clinical complete response (cCR), no visualization of tumor, white or red scar; nearly-cCR, minimal residual nodularity or stenosis; non-cCR, any ulcer with a necrotic bed regardless size, a definite residual mass, or nodularity. Clinical complete response is defined as the complete disappearance of the tumor and/or the absence of residual tumor cells on imaging, endoscopy, and biopsy.
Measured: Up to 24 months
Tumor regression grade (TRG) assessment
TRG according to the Ryan score and the 8th American Joint Committee on Cancer tumor, node, metastasis (AJCC TNM) pathologic staging system in patients randomized in the experimental arm and who underwent surgery.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study startSep 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Pembrolizumab plus a watch-and-wait approach (experimental arm) Standard strategy (surgical resection ±adjuvant chemotherapy (control arm) 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation ARCAD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646445
- Sponsor's protocol ID
- PREMICES G-109 PRODIGE 84
- Acronym
- PREMICES
- Status last verified
- Jun 2025
- First submitted
- 15 Oct 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for Patients With Mismatch Repair-deficient or Microsatellite Instability-high (dMMR/MSI-H) Localized Colon Cancer: a Randomized GERCOR G-109 PRODIGE 84 PREMICES Phase II Trial
- ClinicalTrials.gov ID
- NCT06646445
- Acronym / sponsor ID
- PREMICES / PREMICES G-109 PRODIGE 84
- Conditions
- Colon Cancer
- Keywords
- pembrolizumab, watch-and-wait, microsatellite instability, mismatch repair deficient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Collaborators
- Fondation ARCAD
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this investigational, multicenter, open-label randomized, two-stage phase II study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach in patients with localized deficient mismatch repair / high microsatellite instability (dMMR/MSI-H) colorectal cancer (CRC). The PREMICES trial is based on the hypothesis that non-operative management is effective for dMMR/MSI-H localized CRC when treated with neoadjuvant pembrolizumab.
Eligible patients will be randomized in a 1:1 ratio to receive either pembrolizumab with a watch-and-wait approach (experimental arm A) or the standard strategy of surgical resection ± adjuvant chemotherapy (arm B).
Detailed description
dMMR/MSI-H is a key biomarker for predicting the success of immune checkpoint inhibitors in colorectal cancer (CRC). Pembrolizumab has shown improved outcomes for patients with metastatic CRC, becoming the new standard of care. Neoadjuvant immunotherapy has demonstrated high rates of complete pathological responses in both metastatic and localized CRC, with promising results in non-surgical approaches. Studies support using a "watch-and-wait" strategy after immunotherapy, potentially avoiding surgery. These findings are reshaping treatment strategies for dMMR/MSI-H CRC, particularly regarding organ preservation and non-operative management.
The PREMICES study evaluates the efficacy of neoadjuvant pembrolizumab combined with a watch-and-wait approach for treating localized dMMR/MSI-H CRC. It investigates non-operative management as a potential strategy for achieving a complete clinical response in dMMR/MSI-H localized CRC without the need for surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pembrolizumab plus a watch-and-wait approach (experimental arm) Standard strategy (surgical resection ±adjuvant chemotherapy (control arm) 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm A (Pembrolizumab plus watch-and-wait approach) | Experimental | Drug: Pembrolizumab Injection [Keytruda], Procedure: Watch-and-wait approachPembrolizumab and Watch-and-wait (TAP-CT scan, colonoscopy with biopsies) |
| Arm B (Surgical resection ± adjuvant chemotherapy) | Active comparator | Procedure: Surgery, Drug: Adjuvant chemotherapyStandard of care surgery ± adjuvant chemotherapy (5-fluorouracil/capecitabine ± oxaliplatin 3 months to 6 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Signed and dated informed consent (IC),
- Aged ≥18 years,
- An Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1,
- Newly diagnosed, histologically confirmed colonic or upper third rectal adenocarcinoma, NB: material must be available from biopsy done during colonoscopy.
- Radiological tumor assessment at screening performed within 21 days before inclusion according to RECIST v1.1 by chest, abdomen, and pelvis (TAP- CT) showing resectable localized disease (cT0-4 cN0-2 cM0) and no metastatic disease,
Key exclusion criteria (24 listed)
- Tumor that is not readily resectable,
- Bifocal colorectal adenocarcinoma,
- Locally advanced middle or low rectal cancer (<10 cm from the anal verge on MRI, sagittal slide) staged as cT3/T4 and/or N+ and/or with predictive circumferential margin >2 mm on pretreatment MRI, NB: for rectal cancers, the margin of the tumor relative to the anal margin should be indicated on the endoscopy report,
- Major surgical procedure within 4 weeks prior to the first dose of study treatment,
- Pre-existing hemostatic disorder or medical condition requiring chronic anticoagulation that cannot be interrupted for the purpose of study specified tumor resection or endoscopic biopsies,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab Injection [Keytruda]Also: KeytrudaPembrolizumab 200 mg via a 30-minute IV infusion q3w on Day 1 of each 21-day cycle; 8 cycles ± 9 additional cycles (17 cycles in total). | Drug | Experimental Arm A (Pembrolizumab plus watch-and-wait approach) |
| Watch-and-wait approachWatch-and-wait strategy: * TAP-CT scan At months 3 and 6 during 8 cycles of treatment, at months 9 and 12, and during additional 9 cycles of treatment if performed, and every 3 months thereafter for up to 2 years, * Colonoscopy with biopsies at months 3, 6, 9, 12, and 24. | Procedure or surgery | Experimental Arm A (Pembrolizumab plus watch-and-wait approach) |
| SurgeryStandard of care surgery performed with a maximal delay of 21 days (3 weeks) from randomization. | Procedure or surgery | Arm B (Surgical resection ± adjuvant chemotherapy) |
| Adjuvant chemotherapyAdjuvant chemotherapy (5-fluorouracil/capecitabine ± oxaliplatin 3 months to 6 months) according to the current guidelines, at the investigator's discretion. | Drug | Arm B (Surgical resection ± adjuvant chemotherapy) |
Primary outcome
The rate of success of the experimental strategy at 6 months or after two successive colonoscopies (corresponding to timepoint at 6 months from the experimental strategy) following randomization.
Time frame: 6 months
The success at 6 months is defined as an absence of death, of disease progression, or of decision to perform surgery of the primary tumor for residual cells on biopsies, or for any other reason.
8 secondary outcomes
The rate of strategy success at 24 months
Time frame: 24 months
Incidence of Adverse Events (Safety assessment)
Time frame: Up to 4 years
Overall surival (OS) at 6, 12 and 24 months in both study arms
Time frame: Up to 24 months
Event-free survival (EFS) at 6, 12 and 24 months in both study arms
Time frame: Up to 24 months
30-day and 90-day postoperative morbidity for patients who underwent surgery in both study arms
Time frame: Up to 90 days post-surgery
Time to deterioration (TTD) of health-related quality of life (HRQoL)
Time frame: Up to 4 years
Endoscopic complete response (ecR) assessment
Time frame: Up to 24 months
Tumor regression grade (TRG) assessment
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab Injection [Keytruda], Watch-and-wait approach and Surgery in people with Colon Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 10 sites in France.
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 24 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: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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 Romain Romain, Dr (+33 (1) 49 28 23 45, romain.cohen@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of success of the experimental strategy at 6 months or after two successive colonoscopies (corresponding to timepoint at 6 months from the experimental strategy) following randomization. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2025.