RECRUITING

Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors

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Conditions

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Merkel Cell Carcinoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Merkel Cell Carcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Locally Advanced Cervical CarcinomaLocally Advanced Endometrial CarcinomaLocally Advanced Gastric AdenocarcinomaLocally Advanced Gastroesophageal Junction AdenocarcinomaLocally Advanced Head and Neck Squamous Cell CarcinomaLocally Advanced Hepatocellular CarcinomaLocally Advanced Lung Non-Small Cell CarcinomaLocally Advanced Malignant Solid NeoplasmLocally Advanced MelanomaLocally Advanced Merkel Cell CarcinomaLocally Advanced Renal Cell CarcinomaLocally Advanced Skin Squamous Cell CarcinomaLocally Advanced Triple-Negative Breast CarcinomaLocally Advanced Unresectable Breast CarcinomaLocally Advanced Unresectable Cervical CarcinomaLocally Advanced Unresectable Gastric AdenocarcinomaLocally Advanced Unresectable Gastroesophageal Junction AdenocarcinomaLocally Advanced Unresectable Renal Cell CarcinomaLocally Advanced Urothelial CarcinomaMetastatic Cervical CarcinomaMetastatic Endometrial CarcinomaMetastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hepatocellular CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Merkel Cell CarcinomaMetastatic Renal Cell CarcinomaMetastatic Skin Squamous Cell CarcinomaMetastatic Triple-Negative Breast CarcinomaMetastatic Urothelial CarcinomaPathologic Stage III Cutaneous Melanoma AJCC v8Pathologic Stage III Gastric Cancer AJCC v8Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage III Merkel Cell Carcinoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Gastric Cancer AJCC v8Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Pathologic Stage IIIB Gastric Cancer AJCC v8Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IIIC Gastric Cancer AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Pathologic Stage IV Cutaneous Melanoma AJCC v8Pathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IV Merkel Cell Carcinoma AJCC v8Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8Skin Squamous Cell CarcinomaStage III Cervical Cancer AJCC v8Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage III Hepatocellular Carcinoma AJCC v8Stage III Lung Cancer AJCC v8Stage III Renal Cell Cancer AJCC v8Stage III Uterine Corpus Cancer AJCC v8Stage IIIA Cervical Cancer AJCC v8Stage IIIA Hepatocellular Carcinoma AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIB Cervical Cancer AJCC v8Stage IIIB Hepatocellular Carcinoma AJCC v8Stage IIIB Lung Cancer AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IV Uterine Corpus Cancer AJCC v8Stage IVA Cervical Cancer AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVA Lung Cancer AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVB Cervical Cancer AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Stage IVB Lung Cancer AJCC v8Stage IVB Uterine Corpus Cancer AJCC v8Triple-Negative Breast CarcinomaUnresectable Cervical CarcinomaUnresectable Endometrial CarcinomaUnresectable Gastric AdenocarcinomaUnresectable Gastroesophageal Junction AdenocarcinomaUnresectable Head and Neck Squamous Cell CarcinomaUnresectable Hepatocellular CarcinomaUnresectable Lung Non-Small Cell CarcinomaUnresectable Malignant Solid NeoplasmUnresectable MelanomaUnresectable Merkel Cell CarcinomaUnresectable Renal Cell CarcinomaUnresectable Skin Squamous Cell CarcinomaUnresectable Triple-Negative Breast CarcinomaUnresectable Urothelial Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase I trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.

Official Title

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

Quick Facts

Study Start:2022-03-31
Study Completion:2026-02-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05269381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PRE-REGISTRATION COHORT 1 ONLY: Histologically confirmed unresectable locally advanced or metastatic solid malignancies
  2. * PRE-REGISTRATION COHORT 1 ONLY: Has cancer progression after at least one line of standard of care systemic treatment
  3. * PRE-REGISTRATION COHORT 2 ONLY: Histologically confirmed unresectable locally advanced or metastatic solid malignancies that pembrolizumab is Food and Drug Administration (FDA) approved indication including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HSNCC), urothelial carcinoma, any microsatellite instability (MSI)-high tumor, gastric or gastroesophageal junction (GEJ) adenocarcinoma, cervical cancer, hepatocellular carcinoma (HCC), merkel cell carcinoma (MCC), renal cell carcinoma (RCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma (cSCC), and triple-negative breast cancer (TNBC) or other solid tumors that will benefit from pembrolizumab per the treating physician's judgment.
  4. * PRE-REGISTRATION COHORT 2 ONLY: Patient is eligible to receive pembrolizumab with or without chemotherapy per the treating physician's judgement or has been on pembrolizumab through compassionate use
  5. * PRE-REGISTRATION: Age \>= 18 years
  6. * PRE-REGISTRATION: Willing to provide mandatory tissue specimens per protocol
  7. * NOTE: This includes mandatory fresh tissue specimen at pre-registration for complete exome and transcriptome sequencing unless patient had sequencing under Mayo Institutional Review Board (IRB) protocol #13-000942, #14-004094, or #21-007742 and has been identified for potential production of REAL Neo vaccine. Patients who had sequencing under Mayo IRB protocol #13-000942, #14-004094, or #21-007742 and have been identified for potential production of REAL Neo vaccine are allowed to proceed with neoantigen production.
  8. * PRE-REGISTRATION: Measurable disease as defined by RECIST (version 1.1) criteria
  9. * NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease or non-measurable disease
  10. * PRE-REGISTRATION: Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy
  11. * PRE-REGISTRATION: Provide written informed consent
  12. * PRE-REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  13. * PRE-REGISTRATION: Willing to provide mandatory blood specimens for correlative research
  14. * PRE-REGISTRATION: Negative pregnancy test done =\< 7 days prior to pre-registration for persons of childbearing potential only
  15. * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  16. * PRE-REGISTRATION: Willing to employ a highly effective method of contraception from the time of pre-registration through 6 months after the final vaccine cycle
  17. * PRE-REGISTRATION: Willing to receive a tetanus vaccination if subject has not had one =\< 1 year prior to pre-registration
  18. * PRE-REGISTRATION: Eastern Cooperative Oncology Group (ECOG) of 0 or 1
  19. * PRE-REGISTRATION: Anticipated life expectancy of \> 6 months
  20. * PRE-REGISTRATION: Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see below limits for inclusion) or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, Grade of 0 or 1, except for toxicities not considered a safety risk per treating investigator (e.g., alopecia or vitiligo).
  21. * PRE-REGISTRATION: Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to pre-registration) (Must be \>= 7 days after most recent transfusion)
  22. * PRE-REGISTRATION: Absolute neutrophil count (ANC) \>= 1500/mm\^3 or \>= 1.5 X 10\^9/L (obtained =\< 28 days prior to pre-registration)
  23. * PRE-REGISTRATION: Platelet count \>= 100,000/mm\^3 or \>= 100 X 10\^9/L (obtained =\< 28 days prior to pre-registration) (Must be \>=7 days after most recent transfusion)
  24. * PRE-REGISTRATION: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 28 days prior to pre-registration)
  25. * PRE-REGISTRATION: Aspartate transaminase (AST) and alanine transaminase (ALT) =\< 3 x ULN or =\< 5 x ULN for patients with liver metastases (obtained =\< 28 days prior to pre-registration)
  26. * PRE-REGISTRATION: Creatinine =\< 1.5 x ULN OR calculated creatinine clearance must be \>= 50 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to pre-registration)
  27. * PRE-REGISTRATION: International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy in which case PT or PTT must be within target range of therapy (obtained =\< 28 days prior to pre-registration)
  28. * REGISTRATION COHORT 1 ONLY: Histologically confirmed unresectable locally advanced or metastatic solid malignancies
  29. * REGISTRATION COHORT 1 ONLY: Has cancer progression after at least one line of standard of care systemic treatment
  30. * REGISTRATION COHORT 2 ONLY: Histologically confirmed unresectable locally advanced or metastatic solid malignancies that pembrolizumab is FDA approved indication (including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HSNCC), urothelial carcinoma, any microsatellite instability (MSI)-high tumor, gastric or gastroesophageal junction (GEJ) adenocarcinoma, cervical cancer, hepatocellular carcinoma (HCC), merkel cell carcinoma (MCC), renal cell carcinoma (RCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma (cSCC), and triple-negative breast cancer (TNBC) or other solid tumors that will benefit from pembrolizumab per the treating physician's judgement.
  31. * REGISTRATION COHORT 2 ONLY: Pembrolizumab without chemotherapy remains as a reasonable treatment option at the treating physician's decision
  32. * REGISTRATION: Age \>= 18 years
  33. * REGISTRATION: Soft tissue lesion amenable for adequate tissue sampling
  34. * NOTE: It should not be tumor which was radiated in the past.
  35. * REGISTRATION: Successful sequencing and production of REAL-Neo vaccine
  36. * REGISTRATION: Measurable disease as defined by RECIST (version 1.1) criteria
  37. * NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease or non-measurable disease
  38. * REGISTRATION: ECOG Performance Status (PS) 0 or 1
  39. * REGISTRATION: Anticipated life expectancy of \> 6 months
  40. * REGISTRATION: Hemoglobin \>= 9.0 g/dl (obtained =\< 14 days prior to registration)
  41. * REGISTRATION: Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 14 days prior to registration)
  42. * REGISTRATION: Platelet count \>= 100,000/mm\^3 (obtained =\< 14 days prior to registration)
  43. * REGISTRATION: Total bilirubin =\< 1.5 x ULN (obtained =\< 14 days prior to registration)
  44. * REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 14 days prior to registration)
  45. * REGISTRATION: PT/INR and aPTT =\< 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy (obtained =\< 14 days prior to registration)
  46. * REGISTRATION: Calculated creatinine clearance \>= 50 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)
  47. * REGISTRATION: Provide written informed consent
  48. * REGISTRATION: Willing to provide mandatory blood specimens for correlative research
  49. * REGISTRATION: Willing to provide mandatory tissue specimens for correlative research
  50. * REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  51. * REGISTRATION: Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy
  52. * REGISTRATION: Negative pregnancy test done =\< 14 days prior to registration for persons of childbearing potential only
  53. * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  54. * REGISTRATION: Willing to employ a highly effective method of contraception from the time of pre-registration through 6 months after the final vaccine cycle
  55. * REGISTRATION: Willing to receive a tetanus vaccination if subject has not had one =\< 1 year prior to pre-registration
  56. * REGISTRATION: Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see below limits for inclusion) or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, Grade of 0 or 1, except for toxicities not considered a safety risk per treating investigator (e.g., alopecia or vitiligo)
  1. * PRE-REGISTRATION: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  2. * Pregnant person
  3. * Nursing person unwilling to stop breast feeding
  4. * Person of childbearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle
  5. * PRE-REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  6. * PRE-REGISTRATION: History of myocardial infarction =\< 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  7. * PRE-REGISTRATION: Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment
  8. * PRE-REGISTRATION: Uncontrolled illness including, but not limited to:
  9. * Ongoing or active infection
  10. * Psychiatric illness/social situations
  11. * Congestive heart failure with New York Heart Association class III or IV; moderate to severe objective evidence of cardiovascular disease
  12. * Stroke =\< 3 months prior to pre-registration
  13. * Significant cardiac arrhythmia or unstable angina
  14. * Any other conditions that would limit compliance with study requirements
  15. * PRE-REGISTRATION: Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
  16. * PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm, except for pembrolizumab
  17. * PRE-REGISTRATION: Any prior hypersensitivity or adverse reaction to GM-CSF
  18. * PRE-REGISTRATION: Other active malignancy =\< 3 years prior to pre-registration
  19. * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
  20. * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  21. * PRE-REGISTRATION: Known history of active autoimmune disease that has required systemic treatment in the =\<30 days (i.e., with use of disease modifying agents, corticosteroids \>10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration.
  22. * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded
  23. * REGISTRATION: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  24. * Pregnant persons
  25. * Nursing persons
  26. * Persons of childbearing potential who are unwilling to employ adequate contraception
  27. * REGISTRATION: Any of the following prior therapies:
  28. * Chemotherapy, experimental drugs (except for pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\< 3 weeks prior to registration
  29. * Radiation =\< 2 weeks prior to registration
  30. * Major Surgery =\< 4 weeks prior to registration
  31. * Received a live vaccine =\< 30 days prior to registration
  32. * NOTE: Recent anti-PD1 or anti-PD-L1, such as pembrolizumab, nivolumab, atezolizumab, and durvalumab, is allowed, but the last dose of anti-PD-1 or anti-PD-L1 treatment should be more than 21 days from first dose of vaccination on the study (for Cohort 2 only)
  33. * Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but the last dose of radiation therapy should be more than 14 days from the first dose of vaccination on the study
  34. * REGISTRATION: CTCAE \>= Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity
  35. * REGISTRATION: Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or a history of rhabdomyolysis
  36. * REGISTRATION: Active autoimmune diseases that require chronic systemic steroids (\> 10 mg daily prednisone equivalent) or immunosuppressive agents
  37. * REGISTRATION: Requirement for systemic corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\< 14 days prior to registration
  38. * NOTE: Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
  39. * REGISTRATION: Evidence of leptomeningeal disease
  40. * REGISTRATION: Central nervous system metastases that are untreated, symptomatic, or require steroids \> 10 mg daily prednisone equivalent
  41. * NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases are defined as follows: No evidence of progression for \>= 4 weeks on brain imaging (either magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan)
  42. * REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Contacts and Locations

Principal Investigator

Yanyan Lou, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Yanyan Lou, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-31
Study Completion Date2026-02-24

Study Record Updates

Study Start Date2022-03-31
Study Completion Date2026-02-24

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage III Merkel Cell Carcinoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Merkel Cell Carcinoma AJCC v8
  • Clinical Stage IVA Gastric Cancer AJCC v8
  • Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVB Gastric Cancer AJCC v8
  • Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Locally Advanced Cervical Carcinoma
  • Locally Advanced Endometrial Carcinoma
  • Locally Advanced Gastric Adenocarcinoma
  • Locally Advanced Gastroesophageal Junction Adenocarcinoma
  • Locally Advanced Head and Neck Squamous Cell Carcinoma
  • Locally Advanced Hepatocellular Carcinoma
  • Locally Advanced Lung Non-Small Cell Carcinoma
  • Locally Advanced Malignant Solid Neoplasm
  • Locally Advanced Melanoma
  • Locally Advanced Merkel Cell Carcinoma
  • Locally Advanced Renal Cell Carcinoma
  • Locally Advanced Skin Squamous Cell Carcinoma
  • Locally Advanced Triple-Negative Breast Carcinoma
  • Locally Advanced Unresectable Breast Carcinoma
  • Locally Advanced Unresectable Cervical Carcinoma
  • Locally Advanced Unresectable Gastric Adenocarcinoma
  • Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma
  • Locally Advanced Unresectable Renal Cell Carcinoma
  • Locally Advanced Urothelial Carcinoma
  • Metastatic Cervical Carcinoma
  • Metastatic Endometrial Carcinoma
  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Melanoma
  • Metastatic Merkel Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Metastatic Skin Squamous Cell Carcinoma
  • Metastatic Triple-Negative Breast Carcinoma
  • Metastatic Urothelial Carcinoma
  • Pathologic Stage III Cutaneous Melanoma AJCC v8
  • Pathologic Stage III Gastric Cancer AJCC v8
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage III Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIA Gastric Cancer AJCC v8
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIB Gastric Cancer AJCC v8
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIC Gastric Cancer AJCC v8
  • Pathologic Stage IIID Cutaneous Melanoma AJCC v8
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Pathologic Stage IV Gastric Cancer AJCC v8
  • Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IV Merkel Cell Carcinoma AJCC v8
  • Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Skin Squamous Cell Carcinoma
  • Stage III Cervical Cancer AJCC v8
  • Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage III Renal Cell Cancer AJCC v8
  • Stage III Uterine Corpus Cancer AJCC v8
  • Stage IIIA Cervical Cancer AJCC v8
  • Stage IIIA Hepatocellular Carcinoma AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIA Uterine Corpus Cancer AJCC v8
  • Stage IIIB Cervical Cancer AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIB Uterine Corpus Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IIIC Uterine Corpus Cancer AJCC v8
  • Stage IIIC1 Uterine Corpus Cancer AJCC v8
  • Stage IIIC2 Uterine Corpus Cancer AJCC v8
  • Stage IV Cervical Cancer AJCC v8
  • Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8
  • Stage IV Uterine Corpus Cancer AJCC v8
  • Stage IVA Cervical Cancer AJCC v8
  • Stage IVA Hepatocellular Carcinoma AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVA Uterine Corpus Cancer AJCC v8
  • Stage IVB Cervical Cancer AJCC v8
  • Stage IVB Hepatocellular Carcinoma AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Stage IVB Uterine Corpus Cancer AJCC v8
  • Triple-Negative Breast Carcinoma
  • Unresectable Cervical Carcinoma
  • Unresectable Endometrial Carcinoma
  • Unresectable Gastric Adenocarcinoma
  • Unresectable Gastroesophageal Junction Adenocarcinoma
  • Unresectable Head and Neck Squamous Cell Carcinoma
  • Unresectable Hepatocellular Carcinoma
  • Unresectable Lung Non-Small Cell Carcinoma
  • Unresectable Malignant Solid Neoplasm
  • Unresectable Melanoma
  • Unresectable Merkel Cell Carcinoma
  • Unresectable Renal Cell Carcinoma
  • Unresectable Skin Squamous Cell Carcinoma
  • Unresectable Triple-Negative Breast Carcinoma
  • Unresectable Urothelial Carcinoma