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AzTrials

Colorectal CancerPhase 2CHIMERANCT07407465

Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.

A Phase 2 study testing Trastuzumab-Deruxtecan (T-DXd), Capecitabine and Bevacizumab in people with Colorectal Cancer and Colorectal Adenocarcinoma, run by Gruppo Oncologico del Nord-Ovest at 28 sites in 4 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic/locally advanced unresectable colorectal cancer Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trastuzumab-Deruxtecan (T-DXd), Capecitabine and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
28 sitesin 4 countries
Study dates
20 Oct 2025to 20 Oct 2027
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

  • Written informed consent obtained from the patient/legal representative before performing any protocol-related procedures, including screening evaluations.
  • Patient state to comply with all the study procedures and treatments. Patients must be accessible for treatment and follow-up. Patients registered for this trial must be treated and followed at the participating Centre.
  • Age ≥ 18 years at the time of informed consent.
  • ECOG Performance Status ≤ 2.
  • Life expectancy of ≥ 3 months.
  • Have histologically documented adenocarcinoma of the colon or rectum, which is initially metastatic or unresectable locally advanced.
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  • Subjects must be willing to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks (or at least 25 freshly sectioned slides) for translational analyses (sampled before 1st treatment course). If archival tissue is not available for HER2 testing or for exploratory aims, then a newly obtained baseline biopsy of an accessible tumor lesion is required before Cycle 1 Day 1 timeframe. Biopsy must contain adequate tissue for analysis; the following biopsy types are acceptable: resection, excision, punch (skin lesions only) and core needle biopsies.
  • Presence of locally determined HER2 overexpression/amplification defined as IHC 3+ or 2+/ISH amplified on archival/newly obtained tumor tissue, according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines for gastric/gastroesophageal cancer.
  • Have RAS known status and pMMR/MSS status by standard local testing.
  • Have radiographically measurable disease per RECIST v1.1.
  • Have adequate hematological, hepatic, renal, cardiac and coagulation function, as defined below, obtained ≤ 7 days prior to enrollment (Cycle 1 Day 1):
  • Absolute neutrophil count (ANC) ≥ 1500/mm3. (Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1).
  • Platelet count ≥ 100000/mm3. (Platelet transfusion is not allowed within 1 week prior to C1D1)
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 5 x ULN if liver metastases are present).
  • Serum albumin ≥ 2.5 g/dL.
  • Creatinine clearance ≥ 60 mL/min as determined by Cockcroft-Gault (using actual body weight).
  • Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before enrollment.
  • International normalized ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 x ULN.
  • Have had adequate washout period from previous treatment before screening, defined as:
  • ≥ 4 weeks from major surgery.
  • ≥ 4 weeks from radiation therapy, including palliative stereotactic radiation therapy to the chest.
  • ≥ 3 weeks from anti-cancer chemotherapy [immunotherapy (non-antibody-based therapy)], retinoid therapy, hormonal therapy.
  • ≥ 4 weeks from antibody-based anti-cancer therapy
  • ≥ 2 weeks or 5 half-lives (whichever is longer) from targeted agent- and small molecule-based therapy
  • ≥ 6 weeks from nitrosureas or mitomycin C
  • ≥ 1 week from TKIs approved for treatment of patients with non-small-cell lung cancer (baseline CT must be completed after discontinuation of TKI)
  • > 2 weeks from chloroquine/hydroxychloroquine
  • ≥ 2 weeks from cell-free and Concentrated Ascites Reinfusion Therapy (CART), peritoneal shunt or drainage of ascites, pleural or pericardial effusion.
  • Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU/mL) must be available at the screening visit and urine beta- human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of IP. Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
  • Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1. From the time of screening and must agree to continue using such precautions for 7 months after the last dose of investigational product (IP). Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.
  • Female participants must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study.
  • Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period, by employing protocol-recommended methods. In addition, male patients should refrain from fathering a child, or freezing or donating sperm from the time of randomization/enrollment, throughout the study and for 4 months after the last dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Preservation of sperm should be considered prior to enrollment in this study.

Who cannot join

  • Have previously received any systemic anticancer therapy for CRC in the metastatic/locally advanced unresectable setting or have participated in any interventional clinical trial for CRC in the metastatic/locally advanced unresectable setting. Subjects may have received prior fluoropyrimidine with or without oxaliplatin for CRC in the adjuvant or neoadjuvant setting if it was completed > 6 months before enrollment.
  • Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
  • Have previously been treated with an anti-HER2 agent and/or a topoisomerase I inhibitor.
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medications.
  • Have substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
  • Patients with a medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Subjects with troponin levels above ULN at screening (as defined by the manufacturer) and without any myocardial-related symptoms should undergo a cardiologic consultation before enrollment to rule out MI.
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  • Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening 12-lead ECG.
  • Symptomatic arterial hypertension or uncontrolled arterial hypertension, as determined by the investigator.
  • Have a history of (non-infectious) ILD/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.).
  • Any autoimmune, connective tissue, or inflammatory disorders (e.g., Rheumatoid arthritis, Sjögren's, sarcoidosis etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for patients who are included in the study.
  • Prior pneumonectomy (complete).
  • A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
  • Have unresolved toxicities from previous anticancer therapy, defined as toxicity (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade > 2 for at least 3 months before enrollment/cycle 1 day 1 and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy such as: chemotherapy-induced neuropathy and fatigue.
  • Patients with known hypersensitivity to the study drug or to its excipients.
  • Patients with known hypersensitivity to other monoclonal antibodies.
  • Pregnant or breastfeeding female patients, or patients who are planning to become pregnant. Sexually active men not willing to use adequate contraception during whole study period.
  • Previous or concurrent malignancy within 3 years of study entry. Exceptions are adequately resected non-melanoma skin cancer, curatively treated in-situ diseases, and other solid tumors that have been curatively treated.
  • Presence of any of the following dihydropyrimidine dehydrogenase (DPYD) polymorphism, based on local laboratory testing: DPYD 2a (c.1905+1G>A); DPYD13 (c.1679 T>G); DPYD D949V (c.2846 A>T). French and German patients may undergo baseline uracilemia assessment as detailed below in spite of polymorphism testing.
  • Have a history of transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery within 6 months prior to enrollment (Cycle 1 Day 1).
  • Have a history of a significant bleeding event (e.g., bleeding needing medical intervention) within 6 months prior to enrollment (Cycle 1 Day 1) unless the source of bleeding has been definitively treated.
  • Have a history of GI perforation within 12 months prior to enrollment (Cycle 1 Day 1).
  • Major surgical procedure or significant traumatic injury ≤ 28 days prior to enrollment (≤ 56 days for hepatectomy, open thoracotomy or major neurosurgery) or anticipation of need for major surgical procedure during the course of the study.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Prior organ transplantation, including allogenic stem-cell transplantation.
  • Known history of HIV infection.
  • Active infection including tuberculosis, hepatitis B, hepatitis C. Patients positive for hepatitis C (HCV) antibody are eligible only if HCV RNA polymerase chain reaction (PCR) is negative. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible only if meeting the following criteria:
  • HBsAg negativity (for more than 6 months off anti-viral treatment).
  • Anti-HBc positivity (IgG or total Ig).
  • Absence of cirrhosis or fibrosis on prior imaging or biopsy.
  • Absence of HCV co-infection and no history of HCV co-infection.
  • Access to a local HBV expert during and after the study Patients meeting all abovementioned criteria must be closely monitored for HBV reactivation.
  • Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP
  • Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with trial requirements.
  • Use of any disallowed drugs (see Section 7.5).
  • Additional exclusion criteria for France and Germany:
  • Patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (uracilemia ≥ 16 ng/mL)
  • Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.

Trial locations and contacts

28 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Filippo Pietrantonio, MD contact

0039-3407683357

filippo.pietrantonio@istitutotumori.mi.it

Federica M Palermo, Dr contact

chimerastudy@istitutotumori.mi.it

28 sites in 4 countries

Italy16 sites, 16 recruiting

  • Istituto Tumori Bari Giovanni Paolo II

    Bari, Bari, 70124

    Oronzo Brunetti, MD, dr.oronzo.brunetti1983@gmail.com

    Recruiting

  • A.O.U Careggi

    Florence, Firenze, 50134

    Lorenzo Antonuozzo

    Recruiting

  • Istituto Europeo Di Oncologia S.r.l.

    Milan, Italy, 20141

    Davide Ciardiello, MD, +390257489258, davide.ciardiello@ieo.it

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori - Milano

    Milan, Milan, 20133

    Alessandra Raimondi, MD, 0039-0223803835, alessandra.raimondi@istitutotumori.mi.it

    Recruiting

  • Azienda Ospedaliero Universitaria di Modena

    Modena, Missouri, 41124

    Fabio Gelsomino, MD, gelsomino.fabio@aou.mo.it

    Recruiting

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Naples, 80131

    Erika Martinelli, MD, erika.martinelli@unicampania.it

    Recruiting

  • IRCCS Istituto Nazionale Tumori "Fondazione Giovanni Pascale"

    Naples, 80131

    Antonio Avallone, MD

    a.avallone@istitutotumori.na.it

    Recruiting

  • Fondazione IRCCS Istituto Oncologico Veneto

    Padova, 35128

    Sara Lonardi, MD

    Recruiting

  • U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa

    Pisa, 56126

    Chiara Cremolini, MD, PhD, +39050992192, chiaracremolini@gmail.com

    Recruiting

  • Azienda Unita Sanitaria Locale Della Romagna

    Ravenna, Italy, 48121

    Stefano Tamberi, +390544285206, stefano.tamberi@auslromagna.it

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, RM, 00168

    Lisa Salvatore, MD, lisa.salvatore@policlinicogemelli.it

    Recruiting

  • Policlinico Tor Vergata Roma

    Roma, Roma, 00133

    Vincenzo Formica

    Recruiting

  • IFO-Regina Elena Institute for Cancer Research

    Roma, Roma, 00144

    Emanuela Dell'Aquila, MD, emanuela.dellaquila@ifo.it

    Recruiting

  • Humanitas Mirasole S.p.A.

    Rozzano, Italy, 20089

    Alberto Puccini, MD, +390282247255, alberto.puccini@cancercenter.humanitas.it

    Recruiting

  • Azienda Ospedaliera Card. G. Panico

    Tricase, LE, 73039

    Emiliano Tamburini, MD, emilianotamburini@icloud.com

    Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, Udine, 33100

    Maria Elena Casagrande

    Recruiting

Other trials in Italy

France5 sites, 5 recruiting

  • Hopital Prive Jean Mermoz

    Lyon

    Pascal Artru, MD

    Recruiting

  • Hôpital La Timone - APHM

    Marseille

    Laétitia Dahan, Prof

    Recruiting

  • Hopital Saint Louis

    Paris

    Thomas Aparicio, Prof

    Recruiting

  • Centre Hospitalier Universitaire Reims

    Reims

    Olivier Bouché, Prof

    Recruiting

  • Groupe Hospitalier Rance Emeraude

    St-Malo

    Juliette Viaud, MD

    Recruiting

Other trials in France

Spain5 sites, 5 recruiting

  • Hospital del Mar

    Barcelona

    Clara Montagut Viladot, MD

    Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada

    Encarnación González Flores, MD

    Recruiting

  • Hospital Universitario Fundación Jiménez

    Madrid

    Raquel Fuentes Mateos, MD

    Recruiting

  • Hospital Clínico Universitario Santiago de Compostela

    Santiago de Compostela

    Sonia Candamio Folgar, MD

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia

    Susana Roselló Keranen, MD

    Recruiting

Other trials in Spain

Germany2 sites, 2 recruiting

  • Charite Universitaetsmedizin

    Berlin

    Dominik P Modest, Prof

    Recruiting

  • Krankenhaus Nordwest

    Frankfurt

    Thorsten Götze, MD

    Recruiting

Other trials in Germany

About this study

Official title: Phase II Single Arm Study of Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer: the CHIMERA Study.

The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic/locally advanced unresectable colorectal cancer

Read the detailed description

This is a multinational, Open-label, Single-arm Phase II trial in which patients with metastatic or locally advanced unresectable HER-2 positive colorectal cancer will receive upfront trastuzumab-deruxtecan, capecitabine and bevacizumab until progressive disease, unacceptable toxicity, consent withdrawal, investigator's decision or study termination, whichever occurs first. The primary endpoint of the study is Overall Response Rate by blinded independent central review. In order to preliminarily assess safety, a safety run-in phase will be conducted. The safety run-in phase will include the first 6 patients enrolled. After 6 patients will have received 3 cycles of study treatment, enrollment will be interrupted. A Safety Monitoring Committee (SMC) will review safety data (including demographics, adverse events, serious adverse events, adverse events of special interest, and relevant laboratory data). The SMC will then provide a recommendation as to whether the study may continue, whether amendment(s) to the protocol should be implemented, or whether the study should be stopped. Recruitment will only be resumed accordingly to SMC decision.

Being tested
Trastuzumab-Deruxtecan (T-DXd), Capecitabine, Bevacizumab
Keywords
colorectal cancer, HER-2 positive, Trastuzumab-deruxtecan, Capecitabine, Bevacizumab, mCRC
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms

What participants receive

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

  • Trastuzumab-Deruxtecan (T-DXd)Drug

    T-DXd at the dose of 5.4 mg/kg intravenous (as a 90 +/- 10 minute infusion) on day 1 every 3 weeks

  • CapecitabineDrug

    1000 mg/sqm bis in die (BID) orally on days 1-14 every 3 weeks

  • BevacizumabDrug

    7.5 mg/kg intravenous (as a 30 minute infusion) on day 1 every 3 weeks

Study groups in NCT07407465
Study groupRoleWhat they receive
Trastuzumab-deruxtecan, capecitabine, bevacizumabExperimental* Trastuzumab-deruxtecan 5.4 mg/Kg, IV, d1 q3w; * Capecitabine 1000 mg/sqm B.I.D, oral, dd1-14 q3w; * Bevacizumab 7.5 mg/kg, IV, d1 q3w; Treatment will be received until progressive disease, unacceptable toxicity, consent withdrawal, investigator's decision or study termination, whichever occurs first.
Receives: Drug: Trastuzumab-Deruxtecan (T-DXd); Drug: Capecitabine; Drug: Bevacizumab

What is being measured

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

  1. Overall Response Rate

    Overall response rate will be defined as the proportion of patients who achieve either a partial or complete response as best responses to study treatment according to RECIST v1.1 criteria. Response will be assessed as per blinded independent central review

    Measured: 24 months

Secondary outcomes (13)

  1. Progression-free survival

    Progression-free survival is defined as the time from treatment start to radiological evidence of disease progression (as per RECIST v1.1 criteria) or death, whichever occurs first. PFS will be assessed by BICR and Investigator-assessed.

    Measured: 24 months

  2. Overall survival

    Overall survival is defined as the time from treatment start to death.

    Measured: 48 months

  3. Treatment safety

    Treatment safety is defined as the incidence of adverse events during treatment and follow-up, assessed according to CTCAE v5.0.

    Measured: 24 months

  4. Disease control rate

    Disease control rate (DCR) by BICR and Investigator assessment, defined as the proportion of subjects achieving a complete response (CR), partial response (PR) or stable disease (SD) as best response during study treatment, as per RECIST v1.1.

    Measured: 24 months

  5. Early tumor shrinkage

    Early tumor shrinkage (ETS), defined as the proportion of patients achieving a reduction in tumor size of at least 20% at first radiological reassessment.

    Measured: 24 months

  6. Duration of response

    Duration of response (DOR), defined as the time from first radiological evidence of complete or partial response to disease progression or death whichever occurs first.

    Measured: 24 months

  7. Depth of response

    Depth of response (DoR) defined as the maximum percentage of tumor shrinkage at best response relative to baseline.

    Measured: 24 months

  8. CEA dynamics

    Serum carcinoembryonic antigen (CEA) concentration will be measured in peripheral blood using standard-of-care clinical laboratory immunoassays performed at participating sites. The unit of measure will be ng/mL. CEA kinetics will be summarized as: (i) absolute CEA values (ng/mL) over time; (ii) change from baseline (absolute and percent change); and (iii) CEA normalization (conversion to within institutional normal range) when applicable. CEA dynamics will be assessed at baseline, every 9 (+/-1) weeks during treatment, at EOT and during follow-up visits through 24 months. Associations will be explored between CEA kinetics and efficacy/activity outcomes including objective response (per RECIST v1.1), duration of response, progression-free survival and overall survival, using correlation/association analyses

    Measured: 24 months

  9. Central review of HER-2 status

    Tumor HER2 status will be centrally assessed on archival tumor tissue on which local HER-2 positivity was assessed. HER-2 testing will be performed by means of immunohistochemistry (IHC) assay with in situ hybridization (ISH) in case of IHC 2+ scores. HER2 status will be evaluated according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines for gastric/gastroesophageal cancer. The measure will be reported as HER2 IHC score category, ISH result (where applicable), and overall central HER2 status (positive vs negative). Concordance between central and local HER2 results will be evaluated using percent agreement (overall/positive/negative agreement as applicable) and Cohen's kappa statistic. Exploratory associations between centrally confirmed HER2 status (and/or HER2 categories) and efficacy/activity outcomes (objective response per RECIST v1.1, progression-free survival, overall survival) will be assessed.

    Measured: 24 month

  10. Quality of life as assessed by the European Organization for Research and Treattment of Cancer (EORTC) QLQ-C30

    Quality of life will be assessed through Patients reported outcomes (completion of quality-of-life questionnaires, European Organization for Research and Treattment of Cancer (EORTC) QLQ-C30 during treatment). Questionnaires will be administered at baseline, every 9 weeks +/- 7 days during treatment and at the end of treatment.

    Measured: 24 months

  11. CA19.9 dynamics

    Serum carbohydrate antigen 19-9 (CA19-9) concentration will be measured in peripheral blood using standard-of-care clinical laboratory immunoassays performed at participating sites. The unit of measure will be U/mL. CA19-9 kinetics will be summarized as: (i) absolute CA19-9 values (U/mL) over time; (ii) change from baseline (absolute and percent change); and (iii) CA19-9 normalization (conversion to within institutional normal range) when applicable. CA19-9 dynamics will be assessed at baseline, every 9 (+/- 1) weeks during treatment, at EOT and during follow-up visits through 24 months. Associations will be explored between CA19-9 kinetics and efficacy/activity outcomes including objective response (per RECIST v1.1), duration of response, progression-free survival and overall survival, using correlation/association analyses.

    Measured: 24 months

  12. Quality of life as assessed by the European Organization for Research and Treattment of Cancer (EORTC) QLQ-CR-29

    Quality of life will be assessed through Patients reported outcomes (completion of quality-of-life questionnaires, European Organization for Research and Treattment of Cancer (EORTC) QLQ-CR-29 during treatment). Questionnaires will be administered at baseline, every 9 weeks +/- 7 days during treatment and at the end of treatment.

    Measured: 24 months

  13. Quality of life as assessed by the European Organization for Research and Treattment of Cancer (EORTC) EuroQol EQ-5D

    Quality of life will be assessed through Patients reported outcomes (completion of quality-of-life questionnaires, European Organization for Research and Treattment of Cancer (EORTC) EuroQol EQ-5D during treatment). Questionnaires will be administered at baseline, every 9 weeks +/- 7 days during treatment and at the end of treatment.

    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 posted12 Feb 2026
  2. Study start20 Oct 2025
  3. Primary completion20 Oct 2027 (estimated)
  4. Study completion20 Oct 2027 (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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07407465
Sponsor's protocol ID
CHIMERA
Other IDs
2024-519479-24-00
Acronym
CHIMERA
Status last verified
Feb 2026
First submitted
10 Dec 2025
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The trial results concerning the primary, secondary and exploratory outcomes will be published according to the standard guidelines. IPD could eventually be requested to the Sponsor and Principal Investigator, who will carefully evaluate the formal and motivated request

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab-Deruxtecan (T-DXd), Capecitabine and Bevacizumab in people with Colorectal Cancer and Colorectal Adenocarcinoma, run by Gruppo Oncologico del Nord-Ovest at 28 sites in 4 countries.

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 34 inclusion and 38 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy, France, Spain, Germany. 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 Filippo Pietrantonio, MD (0039-3407683357, filippo.pietrantonio@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response 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 NCT07407465.

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 17 Feb 2026.

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