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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-567 | Other Identifier | Merck Sharp & Dohme LLC | |
| KEYNOTE-567 | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer
This is an open-label Phase Ib-II trial to evaluate the safety and efficacy of GX-188E (IM administration using Ichor TDS-IM device) + pembrolizumab (P) in patients with advanced HPV-16+ or HPV-18+ cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GX-188E, KEYTRUDA® | Experimental | GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GX-188E | Drug | GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT Evaluation for Safety and Tolerability(Part A) | Patient will be evaluated for the first 21 days for dose-limiting toxicities. | within 21days |
| ORR for Efficacy (Part B&C) | ORR within 24 weeks (ORR24) evaluated by RECIST v1.1 | within 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR for Efficacy (Part A) | Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC) | within 24 weeks |
| BORR (Part B&C) | Best Overall Response Rate(BORR) by RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo-Young Hur, M.D | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | South Korea | ||||
| Keimyung University Dongsan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39823099 | Derived | Lim MC, Choi YJ, Hur SY, Kim YM, No JH, Kim BG, Cho CH, Kim SH, Jeong DH, Lee JK, Kim JH, Choi YJ, Woo JW, Sung YC, Park JS. GX-188E DNA vaccine plus pembrolizumab in HPV 16- and/or 18-positive recurrent or advance cervical cancer: a phase 2 trial. EClinicalMedicine. 2024 Jul 13;74:102716. doi: 10.1016/j.eclinm.2024.102716. eCollection 2024 Aug. | |
| 33271094 |
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Subjects were enrolled in three Parts; 6 subjects in Part A, 31 subjects in Part B (6 rolled over from Part A to Part B) and 65 subjects in Part C (6 rolled over from Part A and 25 from Part B) were enrolled.
Of the 25 subjects enrolled during Part B period, 1 subject completed Part B and rolled over to Part C to continue the study, but died during Part C period. Therefore, this subject was counted as 'Completed' for Part B period, but 'Not Completed due to Death' for Part C period.
A total of 90 subjects were enrolled, of which 25 subjects were considered as screen failures.
Of 90 Screened, 65 met Inclusion/Exclusion Criteria and were Randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm (GX-188E + Pembrolizumab) | Assigned Participants: 65 subjects Intervention: Receiving GX-188E at 2 mg (1mg/site x 2 vaccination sites) at week 1, 2, 4, 7, 13, 19, 46 and 200 mg Pembrolizumab on Day 1 q3 weeks. Design: In Part A, the first 6 subjects were enrolled and evaluated for the first 3 weeks for DLTs. No additional subjects were enrolled until all subjects in Part A completed the DLT window and the treatment regimen was deemed safe. If none or only 1 of the first 6 subjects experienced a DLT the study was moved into Part B. Part B employed a Simon Two-Stage design to evaluate the anti-tumor efficacy of the GX-188E + pembrolizumab at the recommended Phase 2 schedule established as tolerable in Part A. In Stage 1 of Part B, 15 subjects were treated. These might have included any subjects from Part A, who did not experience a DLT, received the recommended Phase 2 treatment regimen, and who were considered evaluable for efficacy. If at least 3 efficacy evaluable subjects from Part B Stage 1 had objective responses within the first 24 weeks of treatment, an additional 13 subjects were enrolled, for a total of 28 efficacy evaluable subjects. For Part C, if at least 8 of the 28 subjects enrolled in Part B, experienced an objective response who were considered evaluable for efficacy, it was considered that ORR satisfied the criteria for study expansion and additional subjects were enrolled in Part C to evaluate the efficacy further in larger population. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2022 | Apr 25, 2025 |
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| KEYTRUDA® | Drug | pembrolizumab(100mg/4mL/vial), Intravenous administration |
|
|
| up to 1 year |
| Time-to-Best Response | Time-to-Best Response by RECIST v1.1 and iRECIST | up to 1 year |
| Duration of Response (DOR) | Duration of Response (DOR) by RECIST v1.1 and iRECIST | up to 1 year |
| Progression-Free Survival (PFS) | 6month- PFS by RECIST v1.1 and iRECIST | up to 6 months |
| Overall Survival (OS) | Overall Survival (OS) by RECIST v1.1 and iRECIST | up to 1 year |
| Daegu |
| 42601 |
| South Korea |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Youn JW, Hur SY, Woo JW, Kim YM, Lim MC, Park SY, Seo SS, No JH, Kim BG, Lee JK, Shin SJ, Kim K, Chaney MF, Choi YJ, Suh YS, Park JS, Sung YC. Pembrolizumab plus GX-188E therapeutic DNA vaccine in patients with HPV-16-positive or HPV-18-positive advanced cervical cancer: interim results of a single-arm, phase 2 trial. Lancet Oncol. 2020 Dec;21(12):1653-1660. doi: 10.1016/S1470-2045(20)30486-1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B |
|
|
| Part C |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GX-188E, KEYTRUDA® | GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled | Count of Participants | Participants |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| PD-L1 expression status | Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled. | Count of Participants | Participants |
| |||||||||||||||||
| Histologic Type | Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled. | Count of Participants | Participants |
| |||||||||||||||||
| HPV type | Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled. | 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 | DLT Evaluation for Safety and Tolerability(Part A) | Patient will be evaluated for the first 21 days for dose-limiting toxicities. | The first 6 subjects (Part A) were enrolled and evaluated for the first 3 weeks (prior to Week 4 Day 1 visit) for DLTs. No additional subjects were enrolled until all subjects in Part A completed the DLT window and the investigational treatment regimen was deemed safe. | Posted | Number | participants | within 21days |
|
|
| ||||||||||||||||||||||||||
| Primary | ORR for Efficacy (Part B&C) | ORR within 24 weeks (ORR24) evaluated by RECIST v1.1 | All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B). | Posted | Number | 95% Confidence Interval | percentage of responders | within 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | ORR for Efficacy (Part A) | Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC) | All efficacy analyses were carried out using the 60 in the Efficacy Evaluable Population, respectively, and ORR24 analysis was performed for 6 subjects in the Part A group. | Posted | Number | 95% Confidence Interval | percentage of responders | within 24 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | BORR (Part B&C) | Best Overall Response Rate(BORR) by RECIST v1.1 | All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B). | Posted | Number | 95% Confidence Interval | percentage of responders | up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Time-to-Best Response | Time-to-Best Response by RECIST v1.1 and iRECIST | All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B). | Posted | Median | 90% Confidence Interval | Months | up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of Response (DOR) by RECIST v1.1 and iRECIST | All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B). | Posted | Median | 95% Confidence Interval | Months | up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | 6month- PFS by RECIST v1.1 and iRECIST | All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B). | Posted | Median | 95% Confidence Interval | Months | up to 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) by RECIST v1.1 and iRECIST | All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B). | Posted | Median | 95% Confidence Interval | Months | up to 1 year |
|
|
24 months
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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 | GX-188E, KEYTRUDA® | GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration | 31 | 65 | 25 | 65 | 54 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Peritonitis | Investigations | MedDRA version 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 24 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 24 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 24 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA version 24 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 24 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA version 24 | Systematic Assessment |
| |
| Urogenital fistula | Renal and urinary disorders | MedDRA version 24 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 24 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 24 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 24 | Systematic Assessment |
| |
| Small intestine carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24 | Systematic Assessment |
| |
| Vaginal fistula | Reproductive system and breast disorders | MedDRA version 24 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA version 24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 24 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 24 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 24 | Systematic Assessment |
| |
| Aspartate aminotransferase increased 0 | Investigations | MedDRA version 24 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 24 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA version 24 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 24 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 24 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 24 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 24 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 24 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 24 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 24 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 24 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 24 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 24 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 24 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 24 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 24 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 24 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 24 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 24 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 24 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 24 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 24 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 24 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 24 | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA version 24 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 24 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 24 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 24 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 24 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA version 24 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 24 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA version 24 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| • Project Lead | Clinical Development | +82-2-6098-2756 | yoonjeong.choi@genexine.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2022 | Apr 25, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604106 | GX-188 vaccine |
| C582435 | pembrolizumab |
Not provided
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Not provided
| Physician Decision |
|
| Physician Decision |
|
| Death |
|
| >=65 years |
|
| Part B |
|
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| Part C |
|
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Negative (<1 CPS) |
|
| Part B |
|
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| Part C |
|
|
| Adenocarcinoma |
|
| Part B |
|
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| Part C |
|
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| HPV-18 or both |
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| Part B |
|
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| Part C |
|
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