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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00771 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 248613 | Other Identifier | Roswell Park Cancer Institute | |
| P30CA016056 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Celldex Therapeutics | INDUSTRY |
| Incyte Corporation | INDUSTRY |
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This partially randomized phase I/IIb trial studies the side effects and best dose of IDO1 inhibitor INCB024360 in combination with DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer who no longer have evidence of disease. Antigens (such as cancer/testis antigen [NY-ESO-1] protein) are found on many cancer cells. Vaccines made from NY-ESO-1 protein may cause the immune system to produce immune cells and antibodies that may help locate the NY-ESO-1 and/or cancer/testis antigen 2 (LAGE-1) antigens on cancer cells. By finding them, the immune system may then work to control or eliminate the remaining cancer cells. INCB024360 is an inhibitor of an enzyme called indoleamine 2,3 dioxygenase (IDO). This enzyme is produced by tumor cells to disable immune cells, and limit the efficacy of immune attack. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401 with poly ICLC and IDO1 inhibitor INCB024360 may generate stronger and more long lasting anti-cancer immune responses in patients with ovarian, fallopian tube, and primary peritoneal cancer in remission.
PRIMARY OBJECTIVES:
I. To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein (DEC-205/NY-ESO-1 fusion protein CDX-1401) with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 (IDO1 inhibitor INCB024360). (Phase I) II. To evaluate toxicity as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. (Phase I) III. To determine the progression free survival (PFS) (primary endpoint) using standard immune-related response criteria (irRC) criteria. (Phase IIb)
SECONDARY OBJECTIVES:
I. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing cancer-testis antigen (NY-ESO-1) specific cellular and humoral immunity.
II. To determine the effectiveness of Sirolimus on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity (Exploratory Cohort ONLY) III. Peripheral blood NY-ESO-1 specific cluster of differentiation (CD)8+ and CD4+ T cells. (Exploratory Cohort ONLY) IV. Peripheral blood NY-ESO-1 specific antibodies.(Exploratory Cohort ONLY) V. Peripheral blood frequency of CD4+CD25+forkhead box P3 (FOXP3)+ regulatory T cells. (Exploratory Cohort ONLY) VI. Pharmacokinetics of INCB02360 in relation to T cell frequency and function in correlation with PFS. (Exploratory Cohort ONLY)
OUTLINE:
PHASE I:
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 via intracutaneous injection on day 1, poly ICLC subcutaneously (SC) on days 1 and 2, and IDO1 inhibitor INCB024360 orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients receive IDO1 inhibitor INCB024360 for up to 7 courses.
PHASE IIb: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC as in Phase I.
ARM II: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, and IDO1 inhibitor INCB024360 as in Phase I.
After completion of study treatment, patients are followed up for 30 days and then at 3, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (CDX-1401, poly ICLC) | Experimental | Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC as in Phase I. |
|
| Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360) | Experimental | Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, and IDO1 inhibitor INCB024360 as in Phase I. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEC-205/NY-ESO-1 Fusion Protein CDX-1401 | Biological | Given via intracutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Safety and Evaluate Toxicity of Fixed Doses for Phase I Patients | To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 300mg, number of Participants with Dose Limiting Toxicities is reported | 28 days |
| Progression Free Survival (PFS) Based on Immune Related Response Criteria (irRC) for Phase II Patients | Percentage of Participants with Progression Free Survival Using irRC Criteria for Phase II Patients are reported. irRC criteria disease progression is defined as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart. | Up to 6 months |
| To Evaluate Toxicity as Defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | All patients enrolled in this study will be eligible for the analysis of toxicity. The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson). | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Titers | Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed. | Up to 12 months |
| Frequency of Memory T Cell Populations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emese Zsiros, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I (CDX-1401, Poly ICLC) | DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles. Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles + INCB024360 (Oral) : 300 mg BID for a total of 7 cycles |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2021 |
Not provided
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|
| Epacadostat | Drug | Given PO |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Pharmacological Study | Other | Correlative studies |
|
| Poly ICLC | Drug | Given SC |
|
|
Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.
| Up to 12 months |
| NY-ESO-1 Specific CD8+ and CD4+ Frequency and Function | Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed. | Up to 12 months |
| T Cell Receptor (TCR) Avidity | Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed. | Up to 12 months |
| Phase IIb arm1 (CDX-1401, Poly ICLC, IDO1 Without Inhibitor INCB024360) |
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles. Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles |
| FG002 | Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360) | DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles. Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles + INCB024360 (Oral) : 300 mg BID for a total of 7 cycles |
| FG003 | Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. ) | DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles. Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles + Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible patients will be women ≥ 18 years, with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after chemotherapy with no evidence of disease or minimal residual disease for primary or recurrent disease.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase I (CDX-1401, Poly ICLC) | DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles. Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles + INCB024360 (Oral) : 300 mg BID for a total of 7 cycles |
| BG001 | Phase IIb arm1 (CDX-1401, Poly ICLC, IDO1 Without Inhibitor INCB024360) | DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles. Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles |
| BG002 | Phase IIb arm2 (CDX-1401, Poly ICLC, With IDO1 Inhibitor INCB024360) | DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles. Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles + INCB024360 (Oral) : 300 mg BID for a total of 7 cycles |
| BG003 | Phase IIb Arm 3 (Exploratory Cohort. Enrollment at Roswell Park Site ONLY. ) | DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles. Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles + Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Determine the Safety and Evaluate Toxicity of Fixed Doses for Phase I Patients | To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 300mg, number of Participants with Dose Limiting Toxicities is reported | Posted | Count of Participants | Participants | 28 days |
|
|
| |||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) Based on Immune Related Response Criteria (irRC) for Phase II Patients | Percentage of Participants with Progression Free Survival Using irRC Criteria for Phase II Patients are reported. irRC criteria disease progression is defined as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart. | Progression free survival rates (proportion) at 6 months are reported. | Posted | Number | 90% Confidence Interval | Proportion of participants w/o Progress | Up to 6 months |
| |||||||||||||||||||||||||||
| Primary | To Evaluate Toxicity as Defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. | All patients enrolled in this study will be eligible for the analysis of toxicity. The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson). | Posted | Number | participants | Up to 12 months |
| |||||||||||||||||||||||||||||
| Secondary | Antibody Titers | Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed. | There were 0 patients with this information analyzed. All efforts were made to retrieve data. | Posted | Up to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Frequency of Memory T Cell Populations | Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed. | There were 0 patients with this information analyzed. All efforts were made to retrieve data. | Posted | Up to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | NY-ESO-1 Specific CD8+ and CD4+ Frequency and Function | Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed. | There were 0 patients with this information analyzed. All efforts were made to retrieve data. | Posted | Up to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | T Cell Receptor (TCR) Avidity | Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed. | There were 0 patients with this information analyzed. All efforts were made to retrieve data. | Posted | Up to 12 months |
|
Between the start date of intervention until 30 days after the last intervention or until the study participant is lost to follow up, the start of new treatment, or until the study investigator assesses the event(s) as stable or irreversible, up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I (CDX-1401, Poly ICLC, and a Fixed Daily Dose of INCB024360 ) | Patients will receive a fixed intracutaneous dose of DEC205mAb-NY-ESO-1 fusion protein (CDX-1401) (Day 1) given with subcutaneous adjuvant poly-ICLC (Day 1 and Day 2) for each 28 day cycle for a total of 5 cycles; and Cohort 1 patient enrollment will begin INCB024360 at a fixed daily dose of BID orally | 0 | 6 | 2 | 6 | 6 | 6 |
| EG001 | Phase II 2a (CDX-1401, Poly ICLC) | Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, without IDO1 inhibitor INCB024360 in phase IIb. DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection Epacadostat: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Poly ICLC: Given SC | 0 | 16 | 1 | 16 | 14 | 16 |
| EG002 | Phase II 2b (CDX-1401, Poly ICLC With INCB024360) | Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, with IDO1 inhibitor INCB024360 in phase IIb. DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given via intracutaneous injection Epacadostat: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Poly ICLC: Given SC | 3 | 15 | 2 | 15 | 15 | 15 |
| EG003 | Phase II 3 (Exploratory Cohort) | 4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC | 0 | 2 | 0 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Cardiac death | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE Version 4.0. | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Asthenia | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Chills | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Early satiety | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Influenza like illness | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Injection site discolouration | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Injection site discomfort | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Injection site erythema | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Injection site nodule | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Injection site pain | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Injection site pruritus | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Injection site swelling | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Oedema | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Pain | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Influenza | Infections and infestations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | CTCAE Version 4.0. | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | CTCAE Version 4.0. | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE Version 4.0. | Systematic Assessment |
| |
| Splinter | Injury, poisoning and procedural complications | CTCAE Version 4.0. | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Carbon dioxide increased | Investigations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE Version 4.0. | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE Version 4.0. | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | CTCAE Version 4.0. | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE Version 4.0. | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE Version 4.0. | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katy Wang | Roswell Park Comprehensive Cancer Center | 716-845-2300 | chong.wang@roswellpark.org |
| Mar 22, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613752 | epacadostat |
| C019531 | poly ICLC |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
DEC205mAb-NY-ESO-1 fusion protein (1 mg,intracutaneous injection) on Day 1 of each 28 day cycle for a total of 5 cycles. Adjuvant poly-ICLC (1 ml, subcutaneous) on Day 1 and Day 2 of each 28 day cycle for a total of 5 cycles + Sirolimus: 4 cycles of 4 mg/day for 2 weeks followed by 2 weeks off |
|
|
|
| OG003 | Phase IIb Arm 3 (Exploratory Cohort ) | 4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC |
|
|
| OG003 | Phase IIb Arm 3 (Exploratory Cohort ) | 4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC |
|
| OG003 | Phase IIb Arm 3 (Exploratory Cohort ) | 4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC |
|
| OG003 | Phase IIb Arm 3 (Exploratory Cohort ) | 4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC |
|
| OG003 | Phase IIb Arm 3 (Exploratory Cohort ) | 4 cycles of sirolimus in combination with DEC205mAb-NY-ESO-01 fusion protein (CDX-1401) with adjuvant poly-ICLC |
|