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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00114053 | Other Identifier | JHMIRB | |
| MISP53919 | Other Identifier | Merck and Company |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study will be looking at the objective response rate (ORR) as measured by RECIST in in patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated with CY/GVAX in combination with Pembrolizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CY/GVAX with Pembrolizumab | Experimental | During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells for the first 4 cycles of treatment. After cycle 4, cyclophosphamide and GVAX will be administered with every 4th cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CY | Drug | CY is administered intravenously at 200 mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 4.0. | up to 1 year |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilofer Azad, MD | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31876399 | Result | Yarchoan M, Huang CY, Zhu Q, Ferguson AK, Durham JN, Anders RA, Thompson ED, Rozich NS, Thomas DL 2nd, Nauroth JM, Rodriguez C, Osipov A, De Jesus-Acosta A, Le DT, Murphy AG, Laheru D, Donehower RC, Jaffee EM, Zheng L, Azad NS. A phase 2 study of GVAX colon vaccine with cyclophosphamide and pembrolizumab in patients with mismatch repair proficient advanced colorectal cancer. Cancer Med. 2020 Feb;9(4):1485-1494. doi: 10.1002/cam4.2763. Epub 2019 Dec 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CY/GVAX With Pembrolizumab | During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. CY: CY is administered intravenously at 200 mg/m2 GVAX: GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting Pembrolizumab: Pembrolizumab is administered intravenously at 200 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CY/GVAX With Pembrolizumab | During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. CY: CY is administered intravenously at 200 mg/m2 GVAX: GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting Pembrolizumab: Pembrolizumab is administered intravenously at 200 mg |
| 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 |
| 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 | Objective Response Rate (ORR) | ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. | Data to assess objective response was only collected from 14/17 participants. The remaining 3 patients were withdrawn from study therapy for early clinical progression and were not evaluable for this outcome measure. | Posted | Count of Participants | Participants | up to 1 year |
|
1 year
Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.
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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 | CY/GVAX With Pembrolizumab | During each 21 day cycles, Cyclophosphamide (CY) is administered on Day 1 at 200 mg/m2 followed by Pembrolizumab at 200mg, the colon cancer vaccine (GVAX) is administered on Day 2 at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells. CY: CY is administered intravenously at 200 mg/m2 GVAX: GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting Pembrolizumab: Pembrolizumab is administered intravenously at 200 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorders-Corneal transplant rejection | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nilofer Azad, MD | Sidney Kimmel Cancer Center at Johns Hopkins | 410-614-9169 | nazad2@jhmi.edu |
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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 | Jan 17, 2018 | Aug 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| GVAX | Biological | GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting |
|
|
| Pembrolizumab | Drug | Pembrolizumab is administered intravenously at 200 mg |
|
|
Progression-free Survival (PFS) is defined as the number of days from cycle 1, day 1 of immunotherapy until first documented local progression or death due to any cause. PD is >20% increase in sum of diameters of target lesions as assessed using RECIST (version 1.1).
| up to 1 year |
| Overall Survival (OS) | OS is defined as the number of days from start of study treatment to time of death. Individuals will be censored at the date of the last study visit if no event occurs. The estimation method used was Kaplan-Meier. | Up to 1 year |
| Duration of Response (DOR) | Number of weeks from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per RECIST 1.1, CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. | 1 year |
| Withdrawal by Subject |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG scale measures performance status, with scores ranging from 0-5; 0= fully active, performs without restriction, 1= can ambulate, but restricted in physically strenuous activity, 2= ambulatory and capable of self-care, but unable to work, active for >50% of waking hours, 3= limited self-care, confined to bed or chair for >50% of waking hours, 4= completely disabled, totally confined to bed/chair, 5= deceased | Count of Participants | Participants |
|
| Baseline Carcinoembryonic Antigen (CEA) | Median | Inter-Quartile Range | ng/ml |
|
|
|
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 4.0. | Posted | Count of Participants | Participants | up to 1 year |
|
|
|
| Secondary | Progression Free Survival (PFS) | Progression-free Survival (PFS) is defined as the number of days from cycle 1, day 1 of immunotherapy until first documented local progression or death due to any cause. PD is >20% increase in sum of diameters of target lesions as assessed using RECIST (version 1.1). | Posted | Median | 95% Confidence Interval | days | up to 1 year |
|
|
|
| Secondary | Overall Survival (OS) | OS is defined as the number of days from start of study treatment to time of death. Individuals will be censored at the date of the last study visit if no event occurs. The estimation method used was Kaplan-Meier. | Posted | Median | 95% Confidence Interval | days | Up to 1 year |
|
|
|
| Secondary | Duration of Response (DOR) | Number of weeks from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per RECIST 1.1, CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. | There were no patients that had a CR or PR. Therefore, data could not be collected to assess this outcome measure. | Posted | 1 year |
|
|
| 14 |
| 17 |
| 6 |
| 17 |
| 17 |
| 17 |
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Death, Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Neoplasms, progression (Brain metastases) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hemolytic anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Flashing lights | Eye disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Rectal pain | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Edema-limbs | General disorders | Systematic Assessment | and administration site conditions |
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| Fatigue | General disorders | Systematic Assessment | and administration site conditions |
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| Fever | General disorders | Systematic Assessment | and administration site conditions |
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| Flu-like symptoms | General disorders | Systematic Assessment | and administration site conditions |
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| Pain | General disorders | Systematic Assessment | and administration site conditions |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| AST increased | Investigations | Systematic Assessment |
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| CPK increased | Investigations | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Lethargy | Nervous system disorders | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Confusion | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Urine discoloration | Renal and urinary disorders | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
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| Urinary pain | Renal and urinary disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Erectile dysfuntion | Reproductive system and breast disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Post-nasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bruising, vaccine site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperhidrosis, nightsweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema, vaccine site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Induration, vaccine site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain, vaccine site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Macular papular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritis, vaccine site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Warmth, vaccine site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hot Flashes | Vascular disorders | Systematic Assessment |
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| Memory Impairment | Nervous system disorders | Systematic Assessment |
|
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |