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New treatment option for Pancreatic Cancer
Official title Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT04543071
What this study is testing
What is Motixafortide?
Motixafortide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for pancreatic cancer.
Also referred to as BL-8040.
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
- The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is standard treatment for patients with pancreatic adenocarcinoma.
- 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
- Histological or pathological confirmation of metastatic pancreas adenocarcinoma
- Cytologic or histologic proof of pancreas adenocarcinoma needs to be verified by the treating institution pathologist, either from the initial...
- Pathologic confirmation of metastatic (stage IV) disease (unresectable) on research pretreatment biopsy is required prior to initiation of therapy.
- Patients with endocrine or acinar pancreatic carcinoma are not eligible for the study.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You likely can't join if
- Prior systemic therapy for PDAC: Participants may not have had systemic chemotherapy, investigational therapy, or treatment with T-cell...
- Prior radiation therapy for PDAC Participants may not have had radiation therapy to within two weeks prior to initiation of study treatment...
- Prior surgery for PDAC Participants may not have had surgical resection of PDAC prior to initiation of study treatment
- Patients currently receiving any other investigational agents
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 or better, with the exception of alopecia of any grade and Grade ≤...
- Concomitant treatment with other anti-neoplastic agents (hormone therapy acceptable)
See the full eligibility criteria
Who can join
- Histological or pathological confirmation of metastatic pancreas adenocarcinoma
- Cytologic or histologic proof of pancreas adenocarcinoma needs to be verified by the treating institution pathologist, either from the initial diagnostic biopsy or from the required pre-treatment biopsy, prior to...
- Pathologic confirmation of metastatic (stage IV) disease (unresectable) on research pretreatment biopsy is required prior to initiation of therapy.
- Patients with endocrine or acinar pancreatic carcinoma are not eligible for the study.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age ≥18 years
- Adequate hematological and end-organ function (test results from within 14 days prior to initiation of study treatment):
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without granulocyte colony-stimulating factor support
- White Blood Cell Count (WBC) count ≥ 2.5 x 109 /L (2500/uL)
- Lymphocyte count ≥ 0.5 x 109/L (500/uL)
- Platelet count ≥ 100 x 109/L (100,000/uL) without transfusion
- Hgb ≥ 9.0 g/dL
- Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) ≤ 2.5X upper limit of normal (ULN), unless elevated secondary to biliary obstruction from the pancreas mass and amenable to...
- Serum total bilirubin ≤ 1.5X ULN, unless in patients with known Gilbert disease (≤ 3X ULN), or unless elevated secondary to biliary obstruction from the pancreas mass and amenable to decompression prior to...
- Albumin ≥ 3.5 g/dL
- Creatinine within ULN or calculated creatinine clearance (CrCl) \>50 mL/min using the Cockcroft-Gault formula
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5X ULN, except for those on stable anticoagulation for at least two weeks
- Measurable disease according to Immune Modified (IM)-RECIST and tumor accessible for fresh biopsy
- 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: Fertile men must agree to use an effective method of birth control with female partners of childbearing potential (condoms plus an additional contraceptive method such as an injectable or...
- Informed consent: Participants must be willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements.
- Ability to comply: Participants must be able to comply with the study protocol, according to the investigator's judgement.
- DVT testing Participants must have undergone lower extremity dopplers to rule out deep venous thrombosis (DVT) within the screening period, and undergo therapeutic anticoagulation if evidence of DVT is identified.
- Anticoagulation treatment people who are stable on full-dose anticoagulation medication for at least 2 weeks are considered eligible. However, people who have an increased clot burden on full-dose anticoagulation, such...
What rules you out
- Prior systemic therapy for PDAC: 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...
- Prior radiation therapy for PDAC Participants may not have had radiation therapy to within two weeks prior to initiation of study treatment. Participants may not have had previous radiotherapy to the primary pancreas...
- Prior surgery for PDAC Participants may not have had surgical resection of PDAC prior to initiation of study treatment
- Patients currently receiving any other investigational agents
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 or better, with the exception of alopecia of any grade and Grade ≤ 2 peripheral neuropathy
- Concomitant treatment with other anti-neoplastic agents (hormone therapy acceptable)
- Uncontrolled pleural effusion, pericardial effusion, or ascites. people who required drainage within the four weeks prior or require pleural, pericardial, or peritoneal catheters for drainage are ineligible.
- Uncontrolled tumor-related pain Patients requiring narcotic pain medication must be on a stable regimen for at least two weeks prior to study entry.
- History of leptomeningeal or brain/ Central Nervous System (CNS) metastases
- Uncontrolled hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL, or corrected serum calcium \> upper limit of normal) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
- Recent major surgery or significant traumatic injury Participants may not have undergone major surgery or experienced significant traumatic injury within 14 days prior to initiating study treatment, or be recovering...
- Active or history of autoimmune disease or immune deficiency Includes, but is not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- Patients with a history of autoimmune-related hypothyroidism who are on stable thyroid-replacement hormone for the past three months are eligible for the study.
- Patients with controlled Type 1 diabetes mellitus who are on a stable insulin regimen for the past month are eligible for the study.
- 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 following...
- Rash must cover \<10% of body surface area;
- Disease is well-controlled at baseline and requires only low-potency topical corticosteroids;
- No occurrence of 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 idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on...
- Positive for HIV at screening or any time prior to screening Patients without prior positive HIV test result will undergo an HIV test at screening, unless not permitted under local regulations.
- Hepatitis B virus (HBV) infection (chronic or acute) Defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg...
- Active hepatitis C virus (HCV) infection: Defined as positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody...
- Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease, and inherited liver disease.
- Active tuberculosis
- Infection: Patients may not have had a severe infection requiring antibiotic treatment within the two weeks prior to initiation of study treatment. This includes, but is not limited to, hospitalization for complications...
- 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)...
- Left ventricular ejection fraction below institutional lower limit of normal or below 50%, whichever is lower.
- Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females)
- Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
- Prior autologous stem cell, allogeneic stem cell, or solid organ transplantation
- History of other malignancy Patient may not have a history of malignancy other than PDAC within two years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5- year...
- Recent vaccination: Patients may not have been treated with a live, attenuated vaccine within four weeks prior to initiation of study treatment, or anticipate the need for such a vaccine during treatment with cemiplimab...
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known allergy or hypersensitivity to any of the study drug excipients
- Recent immunosuppressive treatment: Patients may not have been treated with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate...
- Pregnancy: Pregnant women are excluded from this study because there is an unknown, but potential risk for adverse events to the fetus. Breastfeeding should be discontinued prior to start of treatment because there is...
- Other contraindicated conditions Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the...
- Uncontrolled psoriasis, porphyria, proximal myopathy or neuropathy
- Severe depression people hospitalized for depression within the past two years, or who have prior suicidal attempts will be excluded.
- Has received transfusions of blood products (including platelets or red blood cells) within 4 weeks prior to study Day 1.
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Providence, Rhode Island, United States
- Milwaukee, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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; Providence, Rhode Island, United States; Milwaukee, Wisconsin, 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.