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New treatment option for Advanced Neuroendocrine Carcinomas of The Digestive System
Official title Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab
ClinicalTrials.gov ID: NCT07061080
What this study is testing
What is Tarlatamab?
Tarlatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced neuroendocrine carcinomas of the digestive system.
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
- Neuroendocrine neoplasms (NENs) comprise a heterogeneous family of neoplasms arising from the neuroendocrine cells localized in endocrine glands or from the diffuse neuroendocrine cells such as in the digestive or lung tract. Treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NEC) is primarily based on chemotherapy regimens, primarily platinum, which achieve limited benefit and a median overall survival of approximately 12 months.
- 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
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.
- Patient is ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Histologically confirmed neuroendocrine carcinomas (NECs) of the digestive system or unknown primary origin. Note: Carcinomas of pulmonary origin are...
- Ki-67 \>20% or mitotic rate \> 20 per 10 HPF.
You likely can't join if
- The following endocrine tumor types may not be included:
- Paraganglioma, adrenal, thyroid parathyroid or pituitary endocrine tumors,
- Large or small cell lung neuroendocrine carcinoma of the lung,
- Neuroendocrine tumors (NETs) of the gastrointestinal tract or unknown origin (i.e. well differentiated tumors)
- History of other malignancy within the past 2 years prior to first dose of tarlatamab except:
- Malignancy (other than in situ) treated with curative intent and with no known active disease present for 2 years before first dose of tarlatamab and...
See the full eligibility criteria
Who can join
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.
- Patient is ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Histologically confirmed neuroendocrine carcinomas (NECs) of the digestive system or unknown primary origin. Note: Carcinomas of pulmonary origin are not eligible.
- Ki-67 \>20% or mitotic rate \> 20 per 10 HPF.
- Metastatic or locally advanced unresectable disease in the second-line treatment, after progression to either:
- first-line therapy with platinum-based chemotherapy,
- first-line combination of immunotherapy chemotherapy (excluding BITE CD3/DLL3).
- At least one measurable lesion as defined by RECIST V1.1 (Appendix 3).
- Only patients with tumors positive for DLL3 as determined by the central laboratory are eligible. DLL3 positivity is defined as ≥1% of DLL3-expressing cells. Note: An archival tumor tissue sample (frozen tumor block or...
- Adequate organ function as defined below
- Neutrophil count (ANC) ≥ 1.5 × 109/L.
- Platelet count ≥ 100 × 109/L.
- Hemoglobin ≥ 9 g/dL.
- Prothrombin time (PT)/INR and Partial Thromboplastin Time (PTT) or Activated Partial Thromboplastin Time (APTT) 1.5 x upper limit of normal (ULN). Patients on chronic anticoagulation therapy who do not meet the criteria...
- Serum bilirubin ≤ 1.5 × ULN or 2 X ULN for people with liver metastases. Note: patients with Gilbert's disease are excluded.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤ 5 xULN for patients with liver metastases.
- Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockroft-Gault formula or as measured by 24 hour urine collection (GFR can also be used instead of CrCl) (see Table 10 for Cockcroft-Gault formula). 10\...
What rules you out
- The following endocrine tumor types may not be included:
- Paraganglioma, adrenal, thyroid parathyroid or pituitary endocrine tumors,
- Large or small cell lung neuroendocrine carcinoma of the lung,
- Neuroendocrine tumors (NETs) of the gastrointestinal tract or unknown origin (i.e. well differentiated tumors)
- History of other malignancy within the past 2 years prior to first dose of tarlatamab except:
- Malignancy (other than in situ) treated with curative intent and with no known active disease present for 2 years before first dose of tarlatamab and felt to be at low risk for recurrence by the treating physician.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated in situ cancer without evidence of disease.
- Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- Adequately treated urothelial papillary non-invasive carcinoma.
- Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab.
- Persistence of any toxicity from prior anti-tumor therapy that has not been resolved to grade ≤ 1 (NCI CTCAE V5.0) or to levels dictated in the eligibility criteria. Note: exception is made with: i) alopecia; ii) grade...
- Major surgery within 28 days of first dose tarlatamab.
- Radiation therapy \< 2 weeks prior to starting study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
- Myocardial infarction, and/or symptomatic congestive heart failure (New York Heart Association class II) within 12 months of first dose of tarlatamab.
- Cardiac ejection fraction \< 50%, presence of clinically significant pericardial effusion or clinically significant electrocardiogram findings.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.
- History of solid organ transplantation.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab.
- Patients who experienced severe, life-threatening or recurrent (grade 2 or higher) immune-mediated adverse events or infusion-related reactions from previous treatments.
- 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.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- History of hypophysitis or pituitary dysfunction.
- Acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.
- Positive tests for Hepatitis B (HBVsAg) or Hepatitis C ribonucleic acid (HCVab) indicating acute or chronic infection.
- Live and live-attenuated vaccination are prohibited within 28 days prior to the first dose of tarlatamab treatment and for the duration of study. Note: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)...
- Patient has known sensitivity and immediate hypersensitivity to any components of tarlatamab or FOLFIRI.
- Pregnant or breastfeeding patients, and patients planning to become pregnant during the study period and same windows as scheduled for contraceptive measures.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor, if consulted, would pose a risk to subject safety, or interfere with...
The study team makes the final eligibility decision.
Where it's taking place
- Brest, Brest, France
- Bordeaux, Cedex, France
- Lille, Lille, France
- Lyon, Lyon, France
- Nantes, Nantes, France
- Toulouse, Toulouse, France
- Vandœuvre-lès-Nancy, Vandœuvre-lès-Nancy Cedex, France
- Villejuif, Villejuif,, France
- Santiago de Compostela, A Coruña, Spain
- Badalona, Barcelona, Spain
- Barcelona, Barcelona, Spain
- Burgos, Burgos, Spain
- Santander, Cantabria, Spain
- Madrid, Madrid, Spain
- Valencia, Valencia, Spain
- Zaragoza, Zaragoza, Spain
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 Brest, Brest, France; Bordeaux, Cedex, France; Lille, Lille, France; Lyon, Lyon, France; Nantes, Nantes, France; Toulouse, Toulouse, France and 10 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.