Recrutement en cours

Pembrolizumab et Odetiglucan pour le cancer colorectal métastatique prédominant du foie

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Ce qui est testé

Pembrolizumab

+ Odetiglucan
Médicament
Qui peut participer

À partir de 18 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel
Date de début : septembre 2025
Voir le détail du protocole

Résumé

Sponsor principalAbramson Cancer Center at Penn Medicine
Contacts de l'étudeMark O'Hara, MDVoir plus de contacts
Dernière mise à jour : 11 décembre 2025
Issu d'une base de données validée par les autorités. Revendiquer cette étude
Date de début de l'étude : 10 septembre 2025Date à laquelle le premier participant a commencé l'étude.

Cet essai clinique se concentre sur les patients atteints de cancer colorectal métastatique, en particulier ceux dont le cancer s'est principalement propagé au foie. L'étude vise à tester la sécurité et l'efficacité de la combinaison de deux médicaments, le pembrolizumab et l'odetiglucan, pour voir s'ils peuvent travailler ensemble pour mieux traiter ce type de cancer. Cette recherche est importante car la découverte de traitements plus efficaces contre le cancer colorectal métastatique pourrait améliorer les résultats pour les personnes concernées, potentiellement conduisant à une survie plus longue et à une meilleure qualité de vie. Les participants à cette étude recevront les traitements dans le cadre de l'essai pour voir comment la combinaison affecte leur cancer. Les chercheurs surveilleront la sécurité de cette combinaison de médicaments et observeront son efficacité dans le contrôle de la croissance du cancer. Grâce à une observation attentive et à la collecte de données, l'étude vise à déterminer les avantages potentiels et les risques associés à l'utilisation de ces médicaments ensemble pour le traitement du cancer colorectal métastatique prédominant du foie.

Titre officielPhase II Trial of Pembrolizumab in Combination With Odetiglucan for Patients With Metastatic Colorectal Adenocarcinoma With Liver Predominant Disease 
NCT07082439
Sponsor principalAbramson Cancer Center at Penn Medicine
Contacts de l'étudeMark O'Hara, MDVoir plus de contacts
Dernière mise à jour : 11 décembre 2025
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
27 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Comment les participants sont répartis entre les groupes de l'étude
Dans ce type d'étude, tous les participants reçoivent le même traitement. Comme il n'y a qu'un seul groupe, aucune répartition ni randomisation n'est nécessaire. Ce format est souvent utilisé pour évaluer un nouveau traitement sans le comparer à un autre.

Autres méthodes de répartition
Répartition aléatoire
: les participants sont assignés au hasard, comme par tirage au sort, pour garantir l'équité et limiter les biais.

Répartition non aléatoire
: basée sur des critères spécifiques comme l'état de santé ou la décision du médecin.

Comment les traitements sont administrés aux participants
Dans ce type d'étude, tous les participants reçoivent le même traitement. Ce modèle est utilisé pour évaluer les effets d'une seule intervention, sans comparaison avec un autre traitement.

Autres façons d'administrer les traitements
Affectation parallèle
: les participants sont répartis en groupes recevant chacun un traitement différent.

Affectation croisée
: les participants passent d'un traitement à un autre au cours de l'étude.

Plan factoriel
: les participants reçoivent des combinaisons de traitements pour évaluer leurs interactions.

Plan séquentiel
: les traitements sont administrés successivement selon un ordre prédéterminé, pouvant varier selon la réaction du participant.

Autre type d'attribution
: L'attribution des traitements ne suit pas de schéma standard ni de protocole prédéfini.

Comment l'efficacité du traitement est contrôlée
Dans ce type d’étude, aucun participant ne reçoit de placebo. Tous reçoivent soit le traitement expérimental, soit un autre traitement actif, souvent le traitement de référence. Ce modèle permet de comparer les effets de deux interventions réelles, sans inclure de substance inactive.

Autres options possibles
Contrôlée par placebo
: un placebo est utilisé pour comparer les effets du traitement expérimental à ceux d'une substance inactive, ce qui permet d'évaluer son efficacité réelle.

Comment la nature du traitement est tenue confidentielle
Dans une étude en ouvert, tous les participants ainsi que les chercheurs savent quel traitement est administré. Ce type de protocole est utilisé lorsqu'il n'est pas nécessaire ou pas possible de masquer les traitements.

Autres méthodes de masquage
Simple aveugle
: les participants ignorent le traitement reçu, mais les chercheurs le connaissent.

Double aveugle
: ni les participants ni les chercheurs ne savent quel traitement est administré.

Triple aveugle
: Les participants, les chercheurs et les personnes qui analysent les résultats ne savent pas quel traitement est administré.

Quadruple aveugle
: Les participants, les chercheurs, les personnes qui analysent les résultats et les professionnels de santé en charge du suivi ne savent pas non plus quel traitement est administré.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 18 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Critères

Inclusion Criteria: * Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic colorectal adenocarcinoma with liver-predominant disease, defined as liver metastases with * No symptomatic lung or bony metastases * No peritoneal carcinomatosis or clinically significant ascites as determined by the investigator Note: at least 1 measurable lesion must be present in the liver to assess response. It is preferable to have at least 1 other lesion present in the liver which can be biopsied. Measurable lesions chosen as target lesions in the liver should not be biopsied if it can be avoided * Patient must have received prior treatment with a fluoropyrimidine, oxaliplatin, irinotecan, and a VEGF inhibitor (e.g., bevacizumab), unless contraindicated. * Patients with KRAS/NRAS/BRAF wild-type cancers must also have received an EGFR inhibitor (e.g., cetuximab or panitumumab) in addition to the aforementioned therapies, unless contraindicated. * Patients who experienced disease recurrence within 6 months of oxaliplatin-containing adjuvant therapy will qualify as having received an oxaliplatin-containing regimen in the metastatic setting. * Tumor must have documented mismatch repair proficiency (MMR proficient) by immunohistochemistry or not microsatellite instability high(non-MSI-H) by PCR. * Participants who have adverse events due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy or persistent alopecia are eligible. * The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. * Have measurable disease based on RECIST 1.1 with at least one measurable lesion in the liver. It is preferable that one additional viable lesion in the liver that could be safely biopsied is also present, but not required for inclusion. Lesions chosen as target lesions in the liver should not be biopsied if possible. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention. * Have a life expectancy of 3 months or greater as assessed by the investigator * Have adequate organ function. Specimens must be collected within 14 days prior to the start of study intervention. * Male participants: A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. Exclusion Criteria: * WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. If the serum pregnancy test is negative, then the participant will be deemed eligible on this criterion. * Has 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 (eg, CTLA-4, OX 40, CD137). * Has previous treatment with odetiglucan * Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to first dose of study treatment. * Has received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation-related toxicities requiring corticosteroids. * Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted. * Has undergone treatment chemoembolization or radioembolization within 6 weeks prior to enrollment on the study * Has undergone hepatic arterial infusion pump placement * Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Has received an investigational agent or has used an investigational device within the shorter of 4 weeks or 5 half-lives of the first dose of study intervention administration. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. * Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid) * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has an active infection requiring systemic therapy. * Has a known history of Human Immunodeficiency Virus (HIV) infection * Note: No HIV testing is required unless mandated by local health authority. * Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Hepatitis B and C screening tests are not required unless the participant has a known history of HBV and HCV infection. Participants may be eligible if the following criteria are met (18a and/or 18b). * Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, have undetectable HBV viral load prior to initiation of study therapy, and should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention * Participants with history HCV infection are eligible if HCV viral load is undetectable at screening and have completed curative anti-viral therapy at least 4 weeks prior to randomization * Has not adequately recovered from major surgery or has ongoing surgical complications. * Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. * Has a clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome within ≤ 6 months prior to start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding or 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. * Has had an allogenic tissue/solid organ transplant.


Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude
Un seul groupe d'intervention 

est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement
Groupe I
Expérimental

Pembrolizumab 200 mg intravenous administration on day 1 of each 3-week cycle until disease progression, unacceptable toxicity or participant withdrawal. Participants who complete study intervention after 2 years of pembrolizumab and odetiglucan without disease progression and subsequently experience disease progression while off of treatment are eligible for up to 1 year of additional pembrolizumab and odetiglucan (second course).

Odetiglucan 4 mg/kg intravenous administration on day 1 of each 3-week cycle until disease progression, unacceptable toxicity or participant withdrawal. Participants who complete study intervention after 2 years of pembrolizumab and odetiglucan without disease progression and subsequently experience disease progression while off of treatment are eligible for up to 1 year of additional pembrolizumab and odetiglucan (second course).
Objectifs de l'étude
Objectifs principaux

Proportion of patients with best response as complete response (CR) or PR (partial response) using RECIST v. 1.1.
Objectifs secondaires

Proportion of patients with best response of CR or PR as assessed by iRECIST.

Proportion of patients with best response of CR or PR as assessed by iRECIST using only target lesions in the liver.

Time from first CR or PR by iRECIST to disease progression or death, whichever occurs first. Censoring will occur at the time of last patient contact if lost to follow-up, or at the time of data cutoff.

Proportion of patients with PR, CR, or stable disease (SD) by iRECIST as best response.

Time from enrollment to disease progression by iRECIST or death, whichever occurs first. Censoring will occur at the time of last patient contact if lost to follow-up, or at the time of data cutoff.

Time from enrollment to death. Censoring will occur at the time of last patient contact if lost to follow-up, or at the time of data cutoff.

Toxicity rates will be assessed as an ordinal measure (e.g., Grade 1 pneumonitis, Grade 2 pneumonitis, etc.) using CTCAE v. 5.0. Toxicity rates will be summarized as a proportion of patients experiencing each toxicity.

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 1 site
Recrutement en cours
Abramson Cancer Center at the University of PennsylvaniaPhiladelphia, United StatesVoir le site

Recrutement en cours
1 Centres d'Étude
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