Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Drug: GEN-001

Drug: pembrolizumab

Drug: mFOLFOX

The capsules taken by mouth. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU)

GEN-001

200 mg given by intravenous (IV) infusion once every 3 weeks

mFOLFOX given by intravenous (IV) once every 2 weeks for only cohort 3

mFOLFOX

Clinical Development Team

Clinical Development

Do-Youn Oh, M.D., PhD

Hyejin Choi

InKeun Park

Joon Oh Park

Sang-cheul Oh

Minsuk Kwon

This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety and efficacy of GEN-001 in combination with pembrolizumab or in combination with pembrolizumab and mFOLFOX for patients with advanced refractory BTC who have progressed after 1 or 2 prior standard therapy and are not candidates for any other standard therapy. The safety run-in phase will be conducted before the main study phase

GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer

A Phase II Study to Evaluate the Safety and the Efficacy of GEN-001 in Combination With Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer

Incidence of dose-limiting toxicity (DLT)

The assessment of the anti-tumor activity per cohort

The assessment the overall safety and tolerability per cohort.

the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first

the time from the start date of treatment to the date of PD by RECIST v1.1 or death due to any cause, whichever occurs first

the time from the start date of treatment to the date of death

Merck Sharp & Dohme LLC

Genome & Company

Adenocarcinoma

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Micronutrients

Bone Density Conservation Agents

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Calcium

Calcium, Dietary

Folinic Acid

The patients will undergo neoadjuvant chemotherapy with mFOLFOX and then an operation and then individualized adjuvant chemotherapy.

No neoadjuvant chemotherapy and surgery and then adjuvant chemotherapy.

oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ

Aiwen Wu, M.D.

Jiafu Ji, M.D.

This is a randomized phase II multicenter controlled study of oxaliplatin, calcium folinate, and 5-fluorouracil (mFOLFOX7) as neoadjuvant chemotherapy for resectable advanced gastric cancer.

Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the control.

The study hypothesis is that the 5 year survival rate will reach 35% from 25% when neoadjuvant chemotherapy is carried out. With the alpha value to be 0.05 and beta value to be 0.80 as well as 10 percent of patients' lost-of-followup, the sample size will be 263.

Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer

Fudan University

Capital Medical University

Peking University

Jiafu Ji

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Immunomodulating Agents

Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with the standard mFOLFOX chemotherapy regimen in participants with gastroesophageal or colorectal cancer.

The RDE of etrumadenant will be determined from the dose escalation part. Etrumadenant will be given in combination with the standard mFOLFOX chemotherapy regimen in participants with gastroesophageal cancer

The RDE of etrumadenant will be determined from the dose escalation part. Etrumadenant will be given in combination with the standard mFOLFOX chemotherapy regimen in participants with colorectal cancer

Etrumadenant is an A2aR and A2bR antagonist.

etrumadenant

Oxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen

Medical Director

This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with mFOLFOX in participants with advanced metastatic gastroesophageal Cancer (GEC) or colorectal cancer (CRC).

In the dose escalation phase, escalating doses of etrumadenant in combination with mFOLFOX at standard doses will be assessed in participants with advanced metastatic GEC or CRC. Eligible participants will receive oral administration of etrumadenant as well as IV infusion of mFOLFOX. The recommended dose for expansion (RDE) of etrumadenant will be determined upon completion of the dose-escalation phase.

In the dose expansion phase, etrumadenant at the RDE in combination with mFOLFOX at standard doses may be assessed in participants with advanced metastatic GEC or CRC.

Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.

A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Gastrointestinal Malignancies

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

Immunomodulatory activity will be assessed by aggregating data from biomarkers collected from peripheral blood samples

Arcus Biosciences, Inc.

Pharmaceutical Solutions

Bevacizumab

Nintedanib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Bevacizumab 5mg/kg once daily every other week

BIBF 1120

mFolfox

mFolfox 6

bevacizumab

Boehringer Ingelheim

The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.

BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer

A Phase I-II Study of BIBF 1120 and FOLFOX Compared to Bevacizumab and FOLFOX in First Line Metastatic Colorectal Cancer Patients

PFS-9 is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death. A patient is defined as progression-free for 9 months if their PFS was at least 270 days. Progression is assessed according to following mentioned RECIST criteria (version 1.0).

1. 20% increase in the sum of the longest diameter of target lesions.
2. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Overall survival is defined as the time from first treatment until death. Greenwood variance was used for the calculation of 95% confidence interval.

PFS is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death throughout the whole study. Progression is assessed according to RECIST criteria (version 1.0). In this endpoint, the Greenwood's variance estimate was used to calculate the Kaplan-Meier progression free survival median and its corresponding 95% confidence interval

Objective response rate is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% confidence interval represent the Clopper-Pearson exact confidence interval

Objective response is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% Confidence interval represent the Clopper- Pearson exact confidence interval.

Surgical excision of the lesions is allowed if the previous assessment of tumoral response occurred after at least 6 cycles of treatment. Resection Rate includes resection rates R0, R1 and R2 before progressive disease.

Peto's variance estimate was used.

For each patient, the minimum percentage increase from baseline measurement (≤ 28 days before the beginning of the treatment) of the sum Longest diameter (LD) of target lesions was calculated based on the measurements of tumor size. The minimum percentage increase has been divided to four groups:

1. \<= - 30%
2. \> - 30% and \< 0%
3. \>= 0% and \< 20%
4. \>=20%

Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).

Percentage of patients with DLTs,AE were observed in Gastrointestinal,Hepatobiliary \& skin and subcutaneous tissue disorder.Drug related DLT was defined:1)Gastrointestinal toxicity(vomiting, nausea and diarrhoea)or hypertension of CTCAEgrade(G)3 despite optimal supportive care/intervention.2)Non-haematological toxicity of G≥3 except AE:alopecia,nail modifications,\& isolated elevation of gamma glutamyl transpeptidase.3)G4 neutropenia for\>7days(not associated with fever≥38.5°C).4)Neutropenia of G≥3 of any duration associated with fever≥38.5ºC.5)Platelets \<25,000/μLorG3 thrombocytopenia associated with bleeding requiring transfusion.6)Inability to resume nintedanib dosing within14days of stopping due to treatment related toxicity.7)ALT and/or AST elevation of G≥3orG≥2 in conjunction with bilirubin G\>1. 8)Inability to recover from increase ALT/AST in conjunction with increase of bilirubin toALT/AST toG≤1 \&bilirubin to normal or baseline within14days after nintedanib treatment interruption

Determination of Maximum Tolerable Dose based on DLT incidence.

Area under the plasma concentration time-curve over 12 hours for Nintedanib in the dosing interval at steady state and normalized by the dosing unit administered (AUCtau,ss,norm) (Phase I)

Maximum plasma concentration for Nintedanib at steady state and normalized by the dosing unit administered (Cmax,ss,norm) (Phase I)

Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 for the change from baseline at 9 months for Global health status scores.

Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for Global health status scores

Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the change from baseline at 9 months for functional scales, Symptom scales Chemotherapy side effects .

The EORTC-QLQ-CR38 was composed of functioning scales (body image, future perspective, sexual enjoyment, sexual functioning) and symptom scales (chemotherapy side effects, defecation problems, symptoms of the gastrointestinal tract, micturition problems,female sexual problems, male sexual problems, stoma related problems, and weight loss).

Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for functional scales and a worse quality of life for symptom scales.

Number of participants for Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the first use of stoma bag.

Exploratory biomarker and pharmacogenetic analysis for Vascular endothelial growth factor (VEGF).

Note: This endpoint was not statistically analysed in this study.

Patients receiving nintedanib 150 mg or 200 mg twice daily plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).

Nintedanib + mFolfox6

Patients receiving bevacizumab 5 mg/kg every other week plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)

Bevacizumab + mFolfox6

Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).

Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).

Total

Age, Continuous

Sex: Female, Male

Treated Set (TS) - The treated set includes all patients who were dispensed and were documented to have taken at least one dose of the trial drug.

Boehringer Ingelheim Call Center

Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)

Progression-free Survival Rate at 9 Months (PFS-9)

Overall Survival

Progression-free Survival (PFS)

Confirmed Objective Response Rate

Unconfirmed Objective Response Rate

Resection Rate

<=-30%

> - 30% and < 0%

>= 0% and < 20%

>=20%

Non-evaluable

Tumor Shrinkage

CTCAE Grade 1

CTCAE Grade 2

CTCAE Grade 3

CTCAE Grade 4

CTCAE Grade 5

Incidence and Intensity of Adverse Events With Grading According CTCAE

Diarrhoea

Hepatotoxicity

Rash maculo-papular

Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)

Nintedanib 150 mg + mFolfox6 (Phase I)

Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).

Nintedanib 200 mg + mFolfox6 (Phase I)

MTD set: The first 12-18 patients randomised to the nintedanib treatment group, treated with nintedanib according to the dose escalation part of the study. The outputs (updated with cleaned and more complete data) that were used to decide on the MTD of nintedanib while the study was ongoing.

Percentage of Patients With Dose Limit Toxicity (DLTs) Incidence During the First Two Treatment Cycles (Phase I).

Maximum Tolerable Dose (MTD)

Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).

Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)

Area Under the Plasma Concentration Time-curve Over 12 Hours for Nintedanib in the Dosing Interval at Steady State and Normalized by the Dosing Unit Administered (AUCtau,ss,Norm) (Phase I)

Maximum Plasma Concentration for Nintedanib at Steady State and Normalized by the Dosing Unit Administered (Cmax,ss,Norm) (Phase I)

Treated Set (TS). Number of analysed patients are the total number of patients who were analysed for the change from baseline at 9 months for Global health status scores

Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-C30 for the Change From Baseline at 9 Months of Global Health Status Scores.

Body image (N=24, 11)

Future perspective (N=25, 11)

Sexual enjoyment (N=2, 3)

Sexual functioning (N=15, 7)

Chemotherapy side effects (N=25, 11)

Defaecation problems (N=17, 8)

Female sexual problems (N=0, 0)

Male sexual problems (N=5, 4)

Micturition problems (N=25,11)

Stoma-related problems (N=4, 2)

Symptoms area of gastro-intestinal tract (N=25,11)

Weight loss (N=25,11)

Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the Change From Baseline at 9 Months.

Baseline

Week 6

Week 12

Week 24

Week 30

Week 54

No use of stoma bag

Number of Participants for Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the First Use of Stoma Bag.

Exploratory Biomarker and Pharmacogenetic Analysis for VEGF

Nintedanib 150 mg + mFolfox6

Nintedanib 200 mg + mFolfox6

Bevacizumab 5 mg + mFolfox6 (Phase II)

Overall Study

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Docetaxel

Nivolumab

Ipilimumab

Nivolumab 240mg "Flatdose" i.v. d1 over 30 min every 2 weeks followed by Ipilimumab 1mg/kg i.v. d1 over 30 min every 6 weeks followed by FOLFOX Oxaliplatin 85 mg/m² iv 2hrs (day 1), Leucovorin 400 mg/m2 iv 2hrs (day 1), Fluorouracil 400 mg/m² iv bolus (day 1), and Fluorouracil 2400 mg/m² iv continuous infusion over 44 hours (day 1+2) every 2 weeks until disease progression or inacceptable toxicity or end of study treatment.

3 cycles of induction chemotherapy with FOLFOX: FOLFOX Oxaliplatin 85 mg/m² iv 2hrs (day 1), Leucovorin 400 mg/m2 iv 2hrs (day 1), Fluorouracil 400 mg/m² iv bolus (day 1), and Fluorouracil 2400 mg/m² iv continuous infusion over 44 hours (day 1+2) every 2 weeks followed by immunotherapy consisting of: 4 administrations of Nivolumab 240mg "Flatdose" i.v. d1 over 30 minutes every 2 weeks and 2 administrations of Ipilimumab 1mg/kg i.v. d1 over 30 minutes every 6 weeks

Sequence as described may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision. After discontinuation of chemotherapy, immunotherapy will be continued consisting of:

Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks until disease progression or inacceptable toxicity or end of study treatment.

FOLFOX Oxaliplatin 85 mg/m² iv 2hrs (day 1), Leucovorin 400 mg/m2 iv 2hrs (day 1), Fluorouracil 400 mg/m² iv bolus (day 1), and Fluorouracil 2400 mg/m² iv continuous infusion over 44 hours (day 1+2) every 2 weeks until disease progression or inacceptable toxicity or end of study treatment.

Nivolumab 240mg "Flatdose" i.v. d1 every 2 weeks followed by FLOT: Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours every 2 weeks until disease progression or inacceptable toxicity or end of study treatment. After completion or discontinuation of chemotherapy, immunotherapy may be continued consisting of: Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks Chemotherapy can also be administered per local standard.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer	NCT05998447	Biliary Tract C...	GEN-001 Pembrolizumab mFOLFOX	19 Years -	Genome & Company
Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer	NCT00591045	Stomach Neoplas... Gastric Cancer	mFOLFOX	30 Years - 70 Years	Peking University
A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies	NCT03720678	GastroEsophagea... Colorectal Canc...	etrumadenant mFOLFOX	18 Years -	Arcus Biosciences, Inc.
BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer	NCT00904839	Colorectal Neop...	BIBF 1120 BIBF 1120 mFolfox Bevacizumab mFolfox 6 bevacizumab	18 Years -	Boehringer Ingelheim
Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer	NCT03647969	Adenocarcinoma ... GastroEsophagea...	Nivolumab Ipilimumab mFOLFOX FLOT	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma	NCT03503630	Locally Advance...	COMPOUND 205526... Radiation Thera... mFOLFOX Total Mesorecta...	18 Years -	American University of Beirut Medical Center
BIBF 1120 Versus Bevacizumab in Metastatic Colorectal Cancer	NCT00904839	Colorectal Neop...	BIBF 1120 BIBF 1120 mFolfox Bevacizumab mFolfox 6 bevacizumab	18 Years -	Boehringer Ingelheim
A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer	NCT04543695	Rectal Cancer	Concurrent Chem... XELOX mFOLFOX TME	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer	NCT04543695	Rectal Cancer	Concurrent Chem... XELOX mFOLFOX TME	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma	NCT03503630	Locally Advance...	COMPOUND 205526... Radiation Thera... mFOLFOX Total Mesorecta...	18 Years -	American University of Beirut Medical Center
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer	NCT05065957	Biliary Tract C...	D07001-softgel ... mFOLFOX	18 Years -	InnoPharmax Inc.

Spots Global Cancer Trial Database for mfolfox

Every month we try and update this database with for mfolfox cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mfolfox

Every month we try and update this database with for mfolfox cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mfolfox cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.