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New treatment option for Colon and Rectal Cancer
Official title Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
ClinicalTrials.gov ID: NCT07433673
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colon and rectal cancer.
Also referred to as Libtayo, cemiplimab-rwlc.
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 study is being conducted to find out if treatment with gemcitabine, cisplatin, nab-paclitaxel, and cemiplimab can shrink previously inoperable tumors enough for surgery.
- Phase 2: a mid-size study of how well it works
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
- Histologically confirmed diagnosis of biliary tract adenocarcinoma (intra- or extra-hepatic, and gallbladder)
- Locally advanced, unresectable BTC without evidence of distant metastatic disease. Patients with surgically unresectable BTC on diagnostic abdominal...
- Tumor involvement of both hepatic lobes and/or vessels
- Vascular invasion of the portal vein or main hepatic artery
- For perihilar tumors: bilateral hepatic duct involvement up to secondary radicles
You likely can't join if
- Histologies other than adenocarcinoma such as mixed hepatocellular carcinoma/cholangiocarcinoma, adenosquamous carcinoma or mixed...
- Has initially resectable disease or distant metastasis, including distant lymph nodes. Resectable BTC include the following: absence of...
- Participants may not have had systemic chemotherapy, investigational therapy, or treatment with T-cell co-stimulating or immune check point blockade...
- Participants receiving any other investigational agents concurrently or other anti-neoplastic agents (hormone therapy acceptable)
- Participants may not have had previous radiotherapy for the biliary tract tumor.
- Patients may not have had surgical resection of biliary tract cancer prior to initiation of study intervention.
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of biliary tract adenocarcinoma (intra- or extra-hepatic, and gallbladder)
- Locally advanced, unresectable BTC without evidence of distant metastatic disease. Patients with surgically unresectable BTC on diagnostic abdominal CT scan or MRI are eligible to participate in the study. Unresectable...
- Tumor involvement of both hepatic lobes and/or vessels
- Vascular invasion of the portal vein or main hepatic artery
- For perihilar tumors: bilateral hepatic duct involvement up to secondary radicles
- Atrophy of one liver lobe with invasion of contralateral vessel and/or bile duct
- Extrahepatic organ tumor invasion, except contiguous involvement of the diaphragm
- Inadequate estimated liver remnant after surgery If resectability cannot be determined based on CT or MRI, an FDG-PET may be performed, and if it cannot be determined based on imaging alone, surgical exploration is...
- Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of cemiplimab added to gemcitabine, cisplatin, and nab-paclitaxel in participants \<18 years of age, children are excluded from...
- Treatment naïve; no prior systemic therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of greater than 3 months.
- Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with...
- Adequate hematological and organ function (test results from within 14 days prior to initiation of study treatment):
- Absolute Neutrophil Count (ANC) ≥ 1.5 × 10\^9/L without granulocyte colony-stimulating factor support
- White blood cell (WBC) count ≥ 2.5 x 10\^9/L (2500/uL)
- Lymphocyte count ≥ 0.5 x 10\^9/L (500/uL)
- Platelet count ≥ 100 x 10\^9/L (100,000/uL) without transfusion
- Hgb ≥ 9.0 g/dL
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN, unless in patients with known Gilbert disease (≤ 3 × ULN), or unless elevated secondary to biliary obstruction due to malignancy amenable to decompression prior to administration of...
- Creatinine within ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min using the Cockcroft-Gault formula
- International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN, except for those on stable anticoagulation for at least two weeks
- Liver function Child-Pugh class A or B7, if there is evidence of cirrhosis
- Criteria for known hepatitis B and C positive people:
- Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment. Participants should remain on antiviral therapy...
- Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative antiviral therapy at least 4 weeks prior to enrollment.
- people who are HIV positive are eligible if their viral load is undetectable at screening and their CD4+ T cell count is ≥ 200 cells/mm3. Caution should be exercised for people on antiretrovirals that may be inhibitors...
- Negative pregnancy test: Women of child-bearing potential must have a negative serum pregnancy test at screening and must agree to use an effective form of contraception from the time of the negative pregnancy test...
- Birth control agreement: The effects of cemiplimab on the developing human fetus are unknown. For this reason and because immunotherapy agents and cytotoxic chemotherapy used in this trial are known to be teratogenic...
- The participant must understand and be willing to sign a written informed consent document which includes agreement that the participant (or insurance) will be charged gemcitabine, cisplatin, nab-paclitaxel.
- The participants must be able to comply with the study protocol, according to the investigator's judgment.
What rules you out
- Histologies other than adenocarcinoma such as mixed hepatocellular carcinoma/cholangiocarcinoma, adenosquamous carcinoma or mixed adenocarcinoma/neuroendocrine carcinoma; ampullary carcinomas are also excluded.
- Has initially resectable disease or distant metastasis, including distant lymph nodes. Resectable BTC include the following: absence of retropancreatic and paraceliac nodal metastases or distant liver metastases...
- Participants may not have had systemic chemotherapy, investigational therapy, or treatment with T-cell co-stimulating or immune check point blockade therapies (including anti-CTLA-4, anti PD-1, and anti PD-L1...
- Participants receiving any other investigational agents concurrently or other anti-neoplastic agents (hormone therapy acceptable)
- Participants may not have had previous radiotherapy for the biliary tract tumor.
- Patients may not have had surgical resection of biliary tract cancer prior to initiation of study intervention.
- Participants may not have undergone major surgery or experienced significant traumatic injury within 14 days prior to initiating study treatment or be recovering from procedure-related adverse events of \> Grade 1.
- An active autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease...
- Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of the...
- Rash must cover \< 10% of body surface area;
- Disease is well-controlled at baseline and requires only low-potency topical corticosteroids;
- No occurrence acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral...
- History of (non-infectious) idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab, gemcitabine, cisplatin, or nab-paclitaxel; or known allergy or sensitivity to any of the study drug...
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
- Peripheral neuropathy \> Grade 2.
- 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...
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, calcineurin inhibitors, and anti-tumor necrosis factor...
- A known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ...
- An active infection requiring systemic therapy.
- Active tuberculosis
- Concurrent active hepatitis B defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
- Received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose...
- Significant cardiovascular disease: Patient may not have significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident)...
- Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females)
- History of autologous stem cell, allogenic stem cell, or solid organ transplant.
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipate the need for such a vaccine during treatment with cemiplimab or within 5 months after the last dose of...
- 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...
- 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. Pregnant...
- In the judgment of the Investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
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 New York, New York, United States. 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.