BridgeMD
New treatment option for Metastatic Colorectal Cancer
Official title - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases
ClinicalTrials.gov ID: NCT06856837
What this study is testing
What is Fruquintinib?
Fruquintinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic colorectal cancer.
Also referred to as Fruzaqla.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, randomized, open-label, multicenter phase II investigating the therapy of Fruquintinib in combination with Tislelizumab in patients with MSS/pMMR metastatic colorectal cancer without liver metastases.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient\ provide signed informed consent form.
- Patient is ≥ 18 years at the time of given informed consent.
- Patient has been diagnosed with histologically or cytologically proven microsatellite stable (MSS)/proficient mismatch repair (pMMR) metastatic...
- Known RAS (KRAS or NRAS) and BRAF V600E mutational status. Note: These mutations are mutually exclusive. Therefore, if one of the factors is mutated...
- Patient without liver metastases (NLM) defined as people without active liver metastases at screening as determined on baseline imaging of the liver...
You likely can't join if
- Patient has known allergic / hypersensitive reactions to at least one of the treatment components
- Patient had previous malignancy other than that under study within 3 years or concomitant malignancy, except: those with a 5-year overall survival...
- Patient received previous treatment with Fruquintinib, trifluridine/tipiracil, regorafenib or an anti-PD-1/anti-PD-L1 antibodies.
- Patient receives current treatment with any anti-cancer therapy, such as systemic immunotherapy, chemotherapy, or hormone therapy within ≤ 2 weeks...
- Patient receives simultaneous treatment with a different anti-cancer therapy other than that provided for in the trial (excluding palliative...
- Patient has known untreated or symptomatic CNS or leptomeningeal metastases.
See the full eligibility criteria
Who can join
- Patient\ provide signed informed consent form.
- Patient is ≥ 18 years at the time of given informed consent.
- Patient has been diagnosed with histologically or cytologically proven microsatellite stable (MSS)/proficient mismatch repair (pMMR) metastatic adenocarcinoma of the colon or rectum, which is not amenable to potentially...
- Known RAS (KRAS or NRAS) and BRAF V600E mutational status. Note: These mutations are mutually exclusive. Therefore, if one of the factors is mutated, it is not required to determine the mutation status of the others, as...
- Patient without liver metastases (NLM) defined as people without active liver metastases at screening as determined on baseline imaging of the liver as performed by CT scan with contrast or MRI. Definitively treated...
- Patient received at least one line of previous treatment with a fluoropyrimidine, oxaliplatin, irinotecan, VEGF(R) and if indicated EGFR and/or BRAF inhibitors in the advanced setting, or the patient has been...
- Patient has an ECOG performance status ≤ 1.
- Patient has a life expectancy \> 16 weeks.
- Patient has adequate hematological, hepatic and renal function.
- Absolute number of neutrophils (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) (or \< 2 x ULN in case of prior liver involvement or Gilbert's disease)
- AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN, AP ≤ 5 x ULN
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured by 24 h urine) ≥ 30 mL/min (i.e., if serum creatinine level is \> 1.5 x ULN, then a 24-hour urine test must be performed to check the creatinine clearance...
- Urinary protein ≤2+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥3+, a 24-hour urine collection for protein must demonstrate \<2000 mg of protein in 24 hours to allow participation in...
- Adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy).
- Female patients of childbearing potential or male patients in Arm B with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that...
- Patient is willing and able to comply with the protocol (including contraceptive measures) for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the trial gender-independently.
What rules you out
- Patient has known allergic / hypersensitive reactions to at least one of the treatment components
- Patient had previous malignancy other than that under study within 3 years or concomitant malignancy, except: those with a 5-year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or adequately...
- Patient received previous treatment with Fruquintinib, trifluridine/tipiracil, regorafenib or an anti-PD-1/anti-PD-L1 antibodies.
- Patient receives current treatment with any anti-cancer therapy, such as systemic immunotherapy, chemotherapy, or hormone therapy within ≤ 2 weeks prior to study treatment start.
- Patient receives simultaneous treatment with a different anti-cancer therapy other than that provided for in the trial (excluding palliative radiotherapy for symptom control).
- Patient has known untreated or symptomatic CNS or leptomeningeal metastases.
- Patient has impaired cardiac function or clinically significant cardiac disease including unstable angina within 6 months before the first dose of study treatment, acute myocardial infarction \ 160 mmHg or diastolic \>...
- Patient has history of uncontrolled infection with human deficiency virus (HIV) or chronic infection with hepatitis B or C virus (HBV, HCV).
- Patient has evidence of bleeding diathesis.
- Patient has history of gastrointestinal perforation or fistulae in past 6 months or risk factors for perforation.
- Patient has grade 3-4 gastrointestinal bleeding within 3 months prior to first dose of trial therapy.
- Use of strong inducers or inhibitors of CYP3A4 within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug (see Appendix 4 for examples).
- Patient had a major surgery within 2 weeks prior to first dose of trial therapy.
- Patient experienced severe, life-threatening, or recurrent (Grade 2 or higher) immune-mediated adverse events (AEs) or infusion-related reactions including those that led to permanent discontinuation while on treatment...
- Patient received prior immunosuppressive therapy: immunosuppressive doses of systemic medications of \> 10 mg/day of prednisone or equivalent must be discontinued ≥ 2 weeks before the first dose of study treatment...
- Patient has active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
- Patient has history of solid organ transplantation .
- Patient has history of thromboembolic events (including deep vein thrombosis and pulmonary embolism) within the past 6 months or history of stroke and/or transient ischemic attack within the last 12 months.
- Patients has evidence of any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect.
- Female patient is pregnant or breast feeding or planning to become pregnant within and up to 6 months after end of treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Linz, Austria
- Salzburg, Austria
- Wiener Neustadt, Austria
- Amberg, Germany
- Bad Saarow, Germany
- Berlin, Germany
- Bochum, Germany
- Düsseldorf, Germany
- Essen, Germany
- Frankfurt, Germany
- Frankfurt am Main, Germany
- Hamburg, Germany
- Herne, Germany
- Karlsruhe, Germany
- München, Germany
- Schweinfurt, Germany
- Trier, Germany
- Ulm, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Linz, Austria; Salzburg, Austria; Wiener Neustadt, Austria; Amberg, Germany; Bad Saarow, Germany; Berlin, Germany and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.