A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma
NCT ID: NCT05529316
Last Updated: 2026-01-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
150 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-12-12
Study Completion Date
2028-02-29
Brief Summary
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This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.
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Detailed Description
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This Phase 2 study will enroll up to approximately 220 evaluable adult participants with a histologically confirmed diagnosis of either Stage III (unresectable) or Stage IV cutaneous melanoma and who have had prior treatments with anti-programmed death (ligand) 1 \[PD-(L)1\].
This study will consist of 2 parts. Part 1 consists of 2 cohorts (Cohorts A and B) that will receive botensilimab monotherapy. In Cohort A, participants refractory to PD-(L)1 will receive botensilimab. In Cohort B, participants refractory to PD-(L)1 and cytotoxic T-lymphocyte antigen 4 (CTLA-4) will receive botensilimab. Part 2 consists of Cohorts A and B that will receive botensilimab combination therapy. In Cohort A, participants refractory to PD-(L)1 will receive botensilimab in combination with balstilimab. In Cohort B, participants refractory to PD-(L)1 and CTLA-4 will receive botensilimab in combination with balstilimab.
This study will consist of 2 parts. Part 1 consists of 2 cohorts (Cohorts A and B) that will receive botensilimab monotherapy. In Cohort A, participants refractory to PD-(L)1 will receive botensilimab. In Cohort B, participants refractory to PD-(L)1 and cytotoxic T-lymphocyte antigen 4 (CTLA-4) will receive botensilimab. Part 2 consists of Cohorts A and B that will receive botensilimab combination therapy. In Cohort A, participants refractory to PD-(L)1 will receive botensilimab in combination with balstilimab. In Cohort B, participants refractory to PD-(L)1 and CTLA-4 will receive botensilimab in combination with balstilimab.
Conditions
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Advanced Melanoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Part 1 Cohort A: Botensilimab
Participants refractory to PD-(L)1 therapy will receive botensilimab intravenously (IV).
Group Type
EXPERIMENTAL
Botensilimab
Intervention Type
DRUG
An anti-CTLA-4 monoclonal antibody
Part 1 Cohort B: Botensilimab
Participants refractory to PD-(L)1 and anti-CTLA-4 therapies will receive botensilimab IV.
Group Type
EXPERIMENTAL
Botensilimab
Intervention Type
DRUG
An anti-CTLA-4 monoclonal antibody
Part 2 Cohort A: Botensilimab + Balstilimab
Participants refractory to PD-(L)1 will receive botensilimab IV in combination with balstilimab IV.
Group Type
EXPERIMENTAL
Botensilimab
Intervention Type
DRUG
An anti-CTLA-4 monoclonal antibody
Balstilimab
Intervention Type
DRUG
An anti-PD-1 monoclonal antibody
Part 2 Cohort B: Botensilimab + Balstilimab
Participants refractory to PD-(L)1 and CTLA-4 will receive botensilimab IV in combination with balstilimab IV.
Group Type
EXPERIMENTAL
Botensilimab
Intervention Type
DRUG
An anti-CTLA-4 monoclonal antibody
Balstilimab
Intervention Type
DRUG
An anti-PD-1 monoclonal antibody
Interventions
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Botensilimab
An anti-CTLA-4 monoclonal antibody
Intervention Type
DRUG
Balstilimab
An anti-PD-1 monoclonal antibody
Intervention Type
DRUG
Other Intervention Names
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AGEN1181
AGEN2034
Eligibility Criteria
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Inclusion Criteria
Cohort A only:
1. Prior treatment with anti-PD-(L)1 therapy (for example, pembrolizumab or nivolumab) for at least 6 weeks and radiologic progression confirmed by 2 scans at least 4 weeks apart, or if symptomatic due to progressive malignancy, then 1 scan showing progression is sufficient.
2. Progression must be either on treatment with anti-PD-(L)1 regimen or ≤ 12 weeks from last anti-PD-(L)1 dose in metastatic setting or ≤ 24 weeks from completion of therapy in adjuvant/ neoadjuvant setting.
3. For Part 2 only, no intervening anti-cancer therapy between the last course of anti-PD-(L)1 treatment and the first dose of study treatment except for local measures (for example, surgical excision, biopsy, focal radiation therapy), or BRAF ± MEK inhibition when applicable in BRAF mutant participants.
Cohort B only:
1. Prior treatment with first-generation anti-CTLA-4 therapy (for example, ipilimumab or tremelimumab) and prior treatment with anti-PD-(L)1 for at least 6 weeks.
2. Progression on most recent anti-cancer therapy.
3. For Part 2 only, no more than 3 prior lines of therapy in the advanced setting for BRAF mutant and no more than 2 prior lines of therapy in the advanced setting in the BRAF wild type.
Cohorts A and B:
1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.
2. Histologically confirmed Stage III (unresectable) or Stage IV histologically confirmed cutaneous melanoma as per the American Joint Committee on Cancer 8th edition staging system.
3. Measurable disease on baseline imaging per RECIST 1.1 criteria.
4. BRAF V600 mutation status or consent to BRAF V600 mutation testing per local institutional standards during the screening period.
5. Life expectancy ≥ 3 months.
6. Eastern Cooperative Oncology Group performance status of 0 or 1.
7. Adequate organ function is defined as the following laboratory values within 14 days of Cycle 1 Day 1 (C1D1):
1. Neutrophils \> 1500/microliter (μL) (stable off any growth factor within 4 weeks of first study treatment administration).
2. Platelets \> 100 × 10\^3/μL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).
3. Hemoglobin \> 8.0 grams/deciliter (g/dL) (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).
4. Creatinine clearance ≥ 45 milliliters/minute (measured or calculated using modification of diet in renal disease).
5. Aspartate aminotransferase/alanine aminotransferase \< 3.0 × upper limit of normal (ULN).
6. Total bilirubin \< 1.5 × ULN, or \< 3.0 × ULN for participants with Gilbert syndrome.
7. Albumin ≥ 3.0 g/dL.
8. International normalized ratio or prothrombin time ≤ 1.5 × ULN and activated partial thromboplastin time ≤ 1.5 × ULN (unless participant is receiving anticoagulant therapy).
8. Participant must provide a formalin-fixed paraffin-embedded tumor tissue sample from the most recent biopsy of a tumor lesion, obtained within 90 days from signing informed consent form. If recent tumor tissue is unavailable or inadequate, a fresh biopsy will be required, unless the Sponsor agrees that it is not safe/feasible.
9. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) and prior to study drug administration. In part 1, WOCBP must agree to use highly effective contraceptive measures starting with the screening visit through 3 months after the last dose of study treatment. In Part 2, WOCBP must agree to use highly effective contraceptive measures starting with the screening visit through 5 months after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
10. In Part 1, male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study, starting with the screening visit through 3 months after the last dose of study treatment is received. In Part 2, male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 5 months after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
1. Prior treatment with anti-PD-(L)1 therapy (for example, pembrolizumab or nivolumab) for at least 6 weeks and radiologic progression confirmed by 2 scans at least 4 weeks apart, or if symptomatic due to progressive malignancy, then 1 scan showing progression is sufficient.
2. Progression must be either on treatment with anti-PD-(L)1 regimen or ≤ 12 weeks from last anti-PD-(L)1 dose in metastatic setting or ≤ 24 weeks from completion of therapy in adjuvant/ neoadjuvant setting.
3. For Part 2 only, no intervening anti-cancer therapy between the last course of anti-PD-(L)1 treatment and the first dose of study treatment except for local measures (for example, surgical excision, biopsy, focal radiation therapy), or BRAF ± MEK inhibition when applicable in BRAF mutant participants.
Cohort B only:
1. Prior treatment with first-generation anti-CTLA-4 therapy (for example, ipilimumab or tremelimumab) and prior treatment with anti-PD-(L)1 for at least 6 weeks.
2. Progression on most recent anti-cancer therapy.
3. For Part 2 only, no more than 3 prior lines of therapy in the advanced setting for BRAF mutant and no more than 2 prior lines of therapy in the advanced setting in the BRAF wild type.
Cohorts A and B:
1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.
2. Histologically confirmed Stage III (unresectable) or Stage IV histologically confirmed cutaneous melanoma as per the American Joint Committee on Cancer 8th edition staging system.
3. Measurable disease on baseline imaging per RECIST 1.1 criteria.
4. BRAF V600 mutation status or consent to BRAF V600 mutation testing per local institutional standards during the screening period.
5. Life expectancy ≥ 3 months.
6. Eastern Cooperative Oncology Group performance status of 0 or 1.
7. Adequate organ function is defined as the following laboratory values within 14 days of Cycle 1 Day 1 (C1D1):
1. Neutrophils \> 1500/microliter (μL) (stable off any growth factor within 4 weeks of first study treatment administration).
2. Platelets \> 100 × 10\^3/μL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).
3. Hemoglobin \> 8.0 grams/deciliter (g/dL) (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).
4. Creatinine clearance ≥ 45 milliliters/minute (measured or calculated using modification of diet in renal disease).
5. Aspartate aminotransferase/alanine aminotransferase \< 3.0 × upper limit of normal (ULN).
6. Total bilirubin \< 1.5 × ULN, or \< 3.0 × ULN for participants with Gilbert syndrome.
7. Albumin ≥ 3.0 g/dL.
8. International normalized ratio or prothrombin time ≤ 1.5 × ULN and activated partial thromboplastin time ≤ 1.5 × ULN (unless participant is receiving anticoagulant therapy).
8. Participant must provide a formalin-fixed paraffin-embedded tumor tissue sample from the most recent biopsy of a tumor lesion, obtained within 90 days from signing informed consent form. If recent tumor tissue is unavailable or inadequate, a fresh biopsy will be required, unless the Sponsor agrees that it is not safe/feasible.
9. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) and prior to study drug administration. In part 1, WOCBP must agree to use highly effective contraceptive measures starting with the screening visit through 3 months after the last dose of study treatment. In Part 2, WOCBP must agree to use highly effective contraceptive measures starting with the screening visit through 5 months after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
10. In Part 1, male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study, starting with the screening visit through 3 months after the last dose of study treatment is received. In Part 2, male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 5 months after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
Exclusion Criteria
Cohort A:
1\. Received prior anti-CTLA-4 therapy.
Cohort B:
1\. Received prior Fc-engineered or Fc-enhanced anti-CTLA-4 therapy (for example, BMS-96218, BMS-986288, HBM4003, XTX101, CTLA-4 targeting bispecific or other approaches such as ONC-392).
Cohorts A and B:
1. Ocular, uveal, or mucosal melanoma.
2. Any persistent toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≥ 2) from prior cancer therapy, excluding endocrinopathies stable on medication, stable neuropathy, and alopecia.
3. Any history of CTCAE Grade ≥ 3 immune-mediated toxicity (excluding endocrinopathies and non-necrotizing/bullous rash) from prior checkpoint inhibitor therapy that required treatment with systemic corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive medications for more than 4 weeks.
4. Refractory ascites require 2 or more therapeutic paracentesis in the last 4 weeks or ≥ 4 within the last 90 days prior to study entry.
5. Bowel obstruction within the past 3 months or an impending bowel obstruction.
6. Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.
7. Active brain metastases or leptomeningeal metastases with the following exceptions:
1. Treated brain metastases require a) surgical resection, or b) stereotactic radiosurgery. These participants must be off steroids ≥ 10 days prior to randomization for the purpose of managing their brain metastases. Repeat brain imaging following surgical resection or stereotactic radiosurgery is not required if their last brain magnetic resonance imaging is within screening window. Whole-brain radiation is not allowed.
2. Untreated isolated brain metastases that are too small for treatment by surgical resection or stereotactic radiosurgery (for example, 1-2 millimeters) and/or of uncertain etiology are potentially eligible but need to be discussed with and approved by the study Medical Monitor.
8. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment (that is, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before the first dose of study treatment and the participant has no evidence of disease). Participants with history of prior early-stage basal/squamous cell skin cancer, low-risk prostate cancer eligible for active surveillance or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.
9. Incomplete resolution of clinically significant adverse events related to most recent therapy/intervention prior to enrollment.
10. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster \< 7 days before C1D1. For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. A booster shot is not required but if given, must be administered \> 7 days from C1D1 or \> 7 days from future cycle on study.
11. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
12. Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
13. History of allogeneic organ transplant, stem cell transplant or bone marrow transplant (autologous stem cell transplant \> 5 years prior to study enrollment with no evidence of disease are eligible unless lymphopenia Grade \> 1 is present).
14. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
15. Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 milligrams \[mg\] daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
16. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting study treatment (that is, with use of disease-modifying agents or immunosuppressive drugs).
17. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the participants participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
18. A WOCBP who is pregnant or breastfeeding or WOCBP who are not willing to employ effective birth control from screening to 90 days after the last dose of botensilimab (whichever is later).
19. Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D1.
20. Uncontrolled infection with human immunodeficiency virus (HIV). Participants on stable highly active antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.
21. Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Participants who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for HBV at screening is not required.
22. Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Participants on or who have received antiretroviral therapy are eligible, provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required.
23. Dependence on total parenteral nutrition.
1\. Received prior anti-CTLA-4 therapy.
Cohort B:
1\. Received prior Fc-engineered or Fc-enhanced anti-CTLA-4 therapy (for example, BMS-96218, BMS-986288, HBM4003, XTX101, CTLA-4 targeting bispecific or other approaches such as ONC-392).
Cohorts A and B:
1. Ocular, uveal, or mucosal melanoma.
2. Any persistent toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≥ 2) from prior cancer therapy, excluding endocrinopathies stable on medication, stable neuropathy, and alopecia.
3. Any history of CTCAE Grade ≥ 3 immune-mediated toxicity (excluding endocrinopathies and non-necrotizing/bullous rash) from prior checkpoint inhibitor therapy that required treatment with systemic corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive medications for more than 4 weeks.
4. Refractory ascites require 2 or more therapeutic paracentesis in the last 4 weeks or ≥ 4 within the last 90 days prior to study entry.
5. Bowel obstruction within the past 3 months or an impending bowel obstruction.
6. Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.
7. Active brain metastases or leptomeningeal metastases with the following exceptions:
1. Treated brain metastases require a) surgical resection, or b) stereotactic radiosurgery. These participants must be off steroids ≥ 10 days prior to randomization for the purpose of managing their brain metastases. Repeat brain imaging following surgical resection or stereotactic radiosurgery is not required if their last brain magnetic resonance imaging is within screening window. Whole-brain radiation is not allowed.
2. Untreated isolated brain metastases that are too small for treatment by surgical resection or stereotactic radiosurgery (for example, 1-2 millimeters) and/or of uncertain etiology are potentially eligible but need to be discussed with and approved by the study Medical Monitor.
8. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment (that is, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before the first dose of study treatment and the participant has no evidence of disease). Participants with history of prior early-stage basal/squamous cell skin cancer, low-risk prostate cancer eligible for active surveillance or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.
9. Incomplete resolution of clinically significant adverse events related to most recent therapy/intervention prior to enrollment.
10. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine or booster \< 7 days before C1D1. For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. A booster shot is not required but if given, must be administered \> 7 days from C1D1 or \> 7 days from future cycle on study.
11. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
12. Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
13. History of allogeneic organ transplant, stem cell transplant or bone marrow transplant (autologous stem cell transplant \> 5 years prior to study enrollment with no evidence of disease are eligible unless lymphopenia Grade \> 1 is present).
14. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
15. Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 milligrams \[mg\] daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
16. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting study treatment (that is, with use of disease-modifying agents or immunosuppressive drugs).
17. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the participants participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
18. A WOCBP who is pregnant or breastfeeding or WOCBP who are not willing to employ effective birth control from screening to 90 days after the last dose of botensilimab (whichever is later).
19. Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D1.
20. Uncontrolled infection with human immunodeficiency virus (HIV). Participants on stable highly active antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.
21. Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Participants who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for HBV at screening is not required.
22. Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Participants on or who have received antiretroviral therapy are eligible, provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required.
23. Dependence on total parenteral nutrition.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Agenus Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Agenus Inc.
Locations
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Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States
Site Status
Virginia K. Crosson Cancer Center at St. Jude Medical Center
Fullerton, California, United States
Site Status
Providence Saint John's Health Center
Santa Monica, California, United States
Site Status
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States
Site Status
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Site Status
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Site Status
Universitair Ziekenhuis Brussel
Jette, , Belgium
Site Status
Oncosite - Centro de Pesquisa Clinica Em Oncologia
Ijuí, , Brazil
Site Status
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
Jaú, , Brazil
Site Status
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, , Brazil
Site Status
INCA II - Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, , Brazil
Site Status
Hospital Sirio Libanes
São Paulo, , Brazil
Site Status
Real e Benemerita Associaçao Portuguesa de Beneficencia - A Beneficencia Portuguesa de Sao Paulo
São Paulo, , Brazil
Site Status
Hospital A.C. Camargo Cancer Center
São Paulo, , Brazil
Site Status
CHU Amiens Picardie - Hopital Sud
Amiens, , France
Site Status
CHU Grenoble-Alpes - Hopital Michallon
La Tronche, , France
Site Status
Centre Leon Berard
Lyon, , France
Site Status
CHU de Nantes
Nantes, , France
Site Status
AP-HP Hopital Saint-Louis
Paris, , France
Site Status
Centre Eugene Marquis
Rennes, , France
Site Status
Gustave Roussy
Villejuif, , France
Site Status
Universitaetsklinikum Essen
Essen, , Germany
Site Status
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Site Status
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Site Status
University Hospital Schleswig-Holstein
Kiel, , Germany
Site Status
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Mainz, , Germany
Site Status
Klinikum der Universitaet München
München, , Germany
Site Status
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Site Status
Universitaetsklinikum Würzburg
Würzburg, , Germany
Site Status
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.
Meldola, , Italy
Site Status
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, , Italy
Site Status
Azienda Ospedaliero Universitaria Senese
Siena, , Italy
Site Status
Blokhin National Medical Research Oncology Centre
Moscow, , Russia
Site Status
Branch Office of "Hadassah Medical Ltd"
Moscow, , Russia
Site Status
Moscow City Oncology Hospital #62
Moscow, , Russia
Site Status
LLC Medical Services
Saint Petersburg, , Russia
Site Status
Clinical Hospital Russian Railways - Medicine
Saint Petersburg, , Russia
Site Status
Petrov National Medical Research Center of Oncology
Saint Petersburg, , Russia
Site Status
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Site Status
Hospital Clinic Barcelona
Barcelona, , Spain
Site Status
Onkologikoa
Donostia / San Sebastian, , Spain
Site Status
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Site Status
Hospital Universitario 12 de Octubre
Madrid, , Spain
Site Status
Hospital Universitario Virgen Macarena
Seville, , Spain
Site Status
Consorcio Hospital General Universitario de Valencia
Valencia, , Spain
Site Status
CHUV - Centre hospitalier universitaire vaudois
Lausanne, , Switzerland
Site Status
Universitaetsspital Zuerich
Zurich, , Switzerland
Site Status
Royal Marsden Foundation Trust
London, , United Kingdom
Site Status
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Site Status
Mount Vernon Cancer Centre
Middlesex, , United Kingdom
Site Status
Countries
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United States
Belgium
Brazil
France
Germany
Italy
Russia
Spain
Switzerland
United Kingdom
Other Identifiers
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2022-500652-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C-800-23
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
A Study of LY3007113 in Participants With Advanced Cancer
NCT01463631
COMPLETED
PHASE1
A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors
NCT05516914
RECRUITING
PHASE1/PHASE2
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC
NCT03184558
TERMINATED
PHASE2
Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer
NCT02531932
COMPLETED
PHASE2
A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
NCT01525589
COMPLETED
PHASE2
Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).
NCT03742349
TERMINATED
PHASE1
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
NCT04872166
RECRUITING
PHASE1
Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negative Breast Cancer)
NCT07255612
NOT_YET_RECRUITING
PHASE2
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
NCT06293898
RECRUITING
PHASE1
IMAGE Study: Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
NCT01939847
COMPLETED
NA
Eribulin Mesylate Combined With Lobaplatin in the Treatment of Recurrent or Metastatic Triple-negative Breast Cancer
NCT05546255
UNKNOWN
PHASE2
A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors
NCT04725331
TERMINATED
PHASE1/PHASE2
Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer
NCT06900647
RECRUITING
PHASE1
Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
NCT05555706
COMPLETED
PHASE2/PHASE3
Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
NCT03023319
COMPLETED
PHASE1
DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
NCT06313086
RECRUITING
PHASE3
A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer
NCT07235618
NOT_YET_RECRUITING
PHASE2
Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer
NCT03202316
ACTIVE_NOT_RECRUITING
PHASE2
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
NCT04740918
TERMINATED
PHASE3
LBH589 Oral in Combination With Carboplatin and Paclitaxel in Advanced Solid Tumors
NCT01159418
UNKNOWN
PHASE1
A Study of ZN-c5 in Subjects With Breast Cancer
NCT03560531
COMPLETED
PHASE1/PHASE2