A Phase 2 interventional study of VGX-3100 and CELLECTRA™ 5PSP in Anal Neoplasm, sponsored by Inovio Pharmaceuticals. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Inovio Pharmaceuticals · Phase 2, Interventional, and Treatment
Among 162 studies in Anus Neoplasms with a site in United States — 28 open to participants now, 42 under way, 3 of them phase 3. Anus Neoplasms · United States.
Among the 162 studies in Anus Neoplasms with a site in United States, this one is the 98th largest by enrollment of the 128 interventional ones that give a count, is one of 8 that started in 2018, is one of 37 in phase 2, and was the 93rd registered.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
Browse Anus Neoplasms studies →28 of the 162 studies in Anus Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Memorial Sloan Kettering Cancer Center · Sites in United States
InduPro, Inc. · Sites in United States
Jennifer Dorth · Sites in United States
Ohio State University Comprehensive Cancer Center · Sites in United States
Alliance for Clinical Trials in Oncology · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 57 Anus Neoplasms studies recruiting now, 46 (81%) set no upper age limit and 7 (12%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
162 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 54 · Phase 2 52 · Phase 3 10
First in 1994; this study’s year is marked. 8 started in 2018.
This study's enrollment of 23 is below the median of 66 across 211 interventional studies indexed under Anus Neoplasms.
Median enrollment 49 across the 128 interventional studies, 99 across the 32 observational. Of the 112 that completed or were terminated, 41 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
32 of 162 have an industry lead sponsor. The 10 most frequent:
Inovio Pharmaceuticals is the lead sponsor of 31 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Inovio Pharmaceuticals has 1 study filed under Anus Neoplasms — fewer than ten, so there is no comparison to draw.
13 of the studies in Anus Neoplasms with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04444921Phase 3National Cancer Institute (NCI)EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients | 2027-03-31 |
| NCT07407647Ohio State University Comprehensive Cancer CenterVaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer | 2026-12-31 |
| NCT05838391Columbia UniversityAdaptive Radiation in Anal Cancer | 2026-12-31 |
| NCT05217940Icahn School of Medicine at Mount SinaiScreening Women With Prior HPV for Anal Neoplasia | 2027-01 |
| NCT05941507LigaChem Biosciences, Inc.A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors | 2027-01 |
Among the 162 studies in Anus Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18. Approximately 24 participants will receive at least 3 doses of VGX-3100.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult participants who were HIV negative with histologically confirmed anal or anal/peri-anal HSIL associated with HPV-16 and/or 18, received four 6 mg doses of VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 40 followed immediately by EP using the CELLECTRA™ 5PSP device.
Biological: VGX-3100 · Device: CELLECTRA™ 5PSP
One milliliter (1 mL) VGX-3100 (deoxyribonucleic acid \[DNA\] plasmids encoding E6 and E7 proteins of HPV types 16 and 18) will be injected IM and delivered by EP using CELLECTRA™ 5PSP on Day 0, Week 4 and Week 12, and potentially Week 40.
IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 5PSP device.
Percentage of Participants With no Histologic Evidence of Anal or Anal/Peri-Anal HSIL and no Evidence of HPV-16/18 at Week 36
Time frame: Week 36
Number of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each Dose
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug.
Time frame: 7 days following each dose: Day 0 (Days 0 to 7), Week 4 (Days 22 to 28), Week 12 (Days 78 to 84), and Week 40 (Days 274 to 280)
Number of Participants With at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: From first injection up to Week 88
Percentage of Participants With no Evidence of Anal or Anal/Peri-Anal HSIL at Week 36
Time frame: Week 36
Percentage of Participants With no Evidence of HPV-16/18 From Intra-Anal and/or Peri-Anal Tissue by Type-Specific HPV Testing at Week 36
Time frame: Week 36
Percentage of Participants With no Evidence of HPV-16/18 From Intra-Anal Swab by Specific HPV Testing at Week 36
Time frame: Week 36
Percentage of Participants With no Evidence of Anal or Anal/Peri-Anal Low-Grade Squamous Intraepithelial Lesion (LSIL) or HSIL at Week 36
Time frame: Week 36
Percentage of Participants With no Progression of Anal or Anal/Peri-Anal HSIL to Carcinoma From Baseline to Week 36
Time frame: From Baseline to Week 36
Percent Change From Baseline in the Number of Intra-Anal and/or Peri-Anal Lesions as Determined by the Investigator at Weeks 36, 64, and 88
Time frame: From Baseline to Weeks 36, 64, and 88
Mean Change From Baseline in Frequency of HPV-16/17 E6/E7-specific CD8+/CD137+ Peripheral Blood Mononuclear Cells (PBMCs) That Were Perforin Positive at Week 15
PBMCs were isolated from whole blood samples. The assessment of cellular immune activity occurred via the application Flow Cytometry for the purposes of performing a Lytic Granule Loading Assay. The Lytic Granule Loading assay examined cluster of differentiation (CD)8/CD137 cellular markers and Perforin (proteins involved in lytic degranulation and cytotoxic potential) intracellular marker. The frequency was presented as number of perforin-positive CD8 i.e., CD8+/ CD137+ PBMCs cells per million CD8+/ CD137+ PBMCs cells.
Time frame: Baseline and Week 15
Percentage of Participants With no Histologic Evidence of Anal or Anal/Peri-Anal HSIL or no Evidence of HPV-16/18 at Week 36
Time frame: Week 36
Percent Change From Baseline in the Size of Peri-Anal Lesions as Determined by the Investigator at Weeks 36, 64, and 88
Time frame: From Baseline to Weeks 36, 64, and 88
Participants were enrolled at study sites in Canada and the United States from 15 May 2018 to 16 June 2020.
| Milestone | VGX-3100 |
|---|---|
| Started | 23 |
| Safety population | 23 |
| Modified intent-to-treat (mitt) population | 23 |
| Completed | 21 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 1 |
| percentage of participants | VGX-3100 |
|---|---|
| Percentage of Participants With no Histologic Evidence of Anal or Anal/Peri-Anal HSIL and no Evidence of HPV-16/18 at Week 36 | 9.1 (1.6 to 25.9) |
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug.
| Participants | VGX-3100 |
|---|---|
| Number of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each Dose | 21 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
| Participants | VGX-3100 |
|---|---|
| Number of Participants With at Least One Adverse Event (AE) | 23 |
| percentage of participants | VGX-3100 |
|---|---|
| Percentage of Participants With no Evidence of Anal or Anal/Peri-Anal HSIL at Week 36 | 13.6 (2.9 to 34.9) |
| percentage of participants | VGX-3100 |
|---|---|
| Percentage of Participants With no Evidence of HPV-16/18 From Intra-Anal and/or Peri-Anal Tissue by Type-Specific HPV Testing at Week 36 | 45.5 (24.4 to 67.8) |
| percentage of participants | VGX-3100 |
|---|---|
| Percentage of Participants With no Evidence of HPV-16/18 From Intra-Anal Swab by Specific HPV Testing at Week 36 | 31.8 (13.9 to 54.9) |
| percentage of participants | VGX-3100 |
|---|---|
| Percentage of Participants With no Evidence of Anal or Anal/Peri-Anal Low-Grade Squamous Intraepithelial Lesion (LSIL) or HSIL at Week 36 | 9.1 (1.1 to 29.2) |
| percentage of participants | VGX-3100 |
|---|---|
| Percentage of Participants With no Progression of Anal or Anal/Peri-Anal HSIL to Carcinoma From Baseline to Week 36 | 100 (84.6 to 100) |
| percent change | VGX-3100 |
|---|---|
| Percent Change From Baseline at Week 36 | -14.2 ± 41.93 |
| Percent Change From Baseline at Week 64 | -3.3 ± 37.91 |
| Percent Change From Baseline at Week 88 | -40.6 ± 46.77 |
PBMCs were isolated from whole blood samples. The assessment of cellular immune activity occurred via the application Flow Cytometry for the purposes of performing a Lytic Granule Loading Assay. The Lytic Granule Loading assay examined cluster of differentiation (CD)8/CD137 cellular markers and Perforin (proteins involved in lytic degranulation and cytotoxic potential) intracellular marker. The frequency was presented as number of perforin-positive CD8 i.e., CD8+/ CD137+ PBMCs cells per million CD8+/ CD137+ PBMCs cells.
| cells/million T cells + PBMCs | VGX-3100 |
|---|---|
| Mean Change From Baseline in Frequency of HPV-16/17 E6/E7-specific CD8+/CD137+ Peripheral Blood Mononuclear Cells (PBMCs) That Were Perforin Positive at Week 15 | 4.491 ± 4.9686 |
| percentage of participants | VGX-3100 |
|---|---|
| Percentage of Participants With no Histologic Evidence of Anal or Anal/Peri-Anal HSIL or no Evidence of HPV-16/18 at Week 36 | 50.0 (28.2 to 71.8) |
Results for this outcome have not been posted.
Collected over From first injection up to Week 88. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VGX-3100 | 0/23 (0%) | 1/23 (4.3%) | 23/23 (100%) |
| Event | VGX-3100 |
|---|---|
| Ankle FractureInjury, poisoning and procedural complications | 1/23 |
| Event | VGX-3100 |
|---|---|
| Injection site painGeneral disorders | 20/23 |
| MyalgiaMusculoskeletal and connective tissue disorders | 17/23 |
| HeadacheNervous system disorders | 15/23 |
| FatigueGeneral disorders | 14/23 |
| NauseaGastrointestinal disorders | 10/23 |
| Upper respiratory tract infectionInfections and infestations | 8/23 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/23 |
| Injection site erythemaGeneral disorders | 7/23 |
| Injection site pruritusGeneral disorders | 6/23 |
| ProctalgiaGastrointestinal disorders | 5/23 |
mITT population included all participants who received at least 1 dose of VGX-3100+EP.
| Age, Continuous(years) | VGX-3100 |
|---|---|
| Mean | 46 ± 12 |
| Sex: Female, Male(Participants) | VGX-3100 |
|---|---|
| Female | 7 |
| Male | 16 |
| Ethnicity (NIH/OMB)(Participants) | VGX-3100 |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | VGX-3100 |
|---|---|
| Race — White | 16 |
| Race — Other | 3 |
| Race — Black or African American | 2 |
| Race — Asian | 2 |
| Region of Enrollment(participants) | VGX-3100 |
|---|---|
| Canada | 4 |
| United States | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Jun 2020, 25 months.
Results were first posted in Jul 2023, 3 years after primary completion. A results delay was requested in Jun 2021.
Of 40 phase 2 interventional studies under Anus Neoplasms, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 105. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: VGX-3100