Clinical trials: Anal Neoplasms
Melanoma, Non Small Cell Lung Cancer
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary
- Trial name
- PRESERVE-009 (NCT05858736)
- Testing
- AI-061
- Where
- 5 sites in Australia
- Volunteers
- 18 people
- Sponsor
- OncoC4, Inc.
Thyroid Cancer, Renal Cell Carcinoma
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
- Conditions
- Thyroid Cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Trial name
- NCT04234113
- Testing
- Nanrilkefusp alfa, Pembrolizumab
- Where
- 12 sites in United States, Czechia and 2 more
- Volunteers
- 115 people
- Sponsor
- SOTIO Biotech AG
Squamous Cell Carcinoma of the Anal Canal
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.
- Trial name
- NCT04472429
- Testing
- carboplatin, paclitaxel, retifanlimab
- Where
- 84 sites in United States, Australia and 11 more
- Volunteers
- 308 people
- Sponsor
- Incyte Corporation
HPV-Related Carcinoma, HPV-Related Cervical Carcinoma
Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
The study will consist of two parts : In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 participants at increasing doses of TG4001 in combination with avelumab according to a 3+3 design.
- Conditions
- HPV-Related Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma
- Trial name
- NCT03260023
- Testing
- TG4001, Avelumab
- Where
- 20 sites in United States, France and 1 more
- Volunteers
- 143 people
- Sponsor
- Transgene
Melanoma, Cervical Carcinoma
A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors
This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess…
- Conditions
- Melanoma, Cervical Carcinoma, Pancreatic Carcinoma, Triple Negative Breast Cancer
- Trial name
- DUET-4 (NCT03849469)
- Testing
- XmAb®22841, Pembrolizumab (Keytruda®)
- Where
- 28 sites in United States
- Volunteers
- 78 people
- Sponsor
- Xencor, Inc.
Human Papillomavirus Infection
A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine
This study is to demonstrate that the administration of the investigational vaccine can reduce the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3)…
- Trial name
- NCT05668572
- Testing
- Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli), Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）
- Where
- 3 sites in China
- Volunteers
- 12,000 people, healthy volunteers welcome
- Sponsor
- Beijing Health Guard Biotechnology, Inc
Anal Cancer Metastatic, Squamous Cell Carcinoma of the Anus Stage Unspecified
A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab
This is an open-label, phase 1/2, multiple-indication platform study to explore safety, potential predictive immune-related biomarkers, and early efficacy (as measured by objective response rate [ORR; Cohorts 1,2, 4,and 5] and…
- Conditions
- Anal Cancer Metastatic, Squamous Cell Carcinoma of the Anus Stage Unspecified, Pancreatic Cancer Metastatic, Unresectable Pancreatic Carcinoma
- Trial name
- GOBLET (NCT07280377)
- Testing
- Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel
- Where
- 15 sites in Germany
- Volunteers
- 122 people
- Sponsor
- Oncolytics Biotech
Cervical Cancer, Anal Cancer
CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers
A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers.
- Conditions
- Cervical Cancer, Anal Cancer, Head and Neck Cancers
- Trial name
- NCT05122221
- Testing
- Fludarabine + Cyclophosphamide, Interleukin-2, CRTE7A2-01 TCR-T Cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Corregene Biotechnology Co., Ltd
Advanced Solid Tumors
A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2).
- Trial name
- NCT05941507
- Testing
- LCB84, Anti-PD-1 monoclonal antibody
- Where
- 8 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- LigaChem Biosciences, Inc.
HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection
Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.
- Conditions
- HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection, Anal Cancer
- Trial name
- NCT03202992
- Testing
- ABI-1968
- Where
- 6 sites in United States, Australia
- Volunteers
- 57 people
- Sponsor
- Antiva Biosciences
HPV-induced Cancers
Immune Therapy of HPV-induced Cancers
Patients with advanced HPV- and p16INK4a-positive cancers will receive the peptide P16_37-63 in combination with Montanide® ISA-51 VG so that an immune response directed against the tumor cells can be induced.
- Trial name
- NCT01462838
- Testing
- P16_37-63
- Where
- Germany
- Volunteers
- 26 people
- Sponsor
- Oryx GmbH & Co. KG
Condylomata Acuminata
Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts
The purpose of this study is to investigate the clinical efficacy, safety and tolerability of a Polyphenon E Ointment 10% and a Polyphenon E Ointment 15% in the treatment of external genitial warts in male and female patients.
- Trial name
- NCT00449982
- Testing
- Polyphenon E Ointment 10%, Polyphenon E Ointment 15%
- Where
- 12 sites in United States, Argentina and 5 more
- Volunteers
- 480 people
- Sponsor
- MediGene
Human Papillomavirus Infection
A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China
The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune…
- Trial name
- NCT05662020
- Testing
- Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli), GARDASIL® 9
- Where
- China
- Volunteers
- 2,750 people, healthy volunteers welcome
- Sponsor
- Beijing Health Guard Biotechnology, Inc
Rectal Adenocarcinoma, Anal Adenocarcinoma
Prospective Validation Study for the Proprietary Rectal and Anal Cancer Protein Expression Assays
Patients with locally advanced rectal and esophageal carcinomas typically undergo neoadjuvant chemoradiation therapy prior to surgical resection.
- Conditions
- Rectal Adenocarcinoma, Anal Adenocarcinoma, Anal Squamous Cell Carcinoma
- Trial name
- NCT02407561
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Castle Biosciences Incorporated
Adult Solid Tumor
Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab or other immune…
- Trial name
- NCT04084951
- Testing
- SQZ-PBMC-HPV, Atezolizumab, Ipilimumab
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- SQZ Biotechnologies
Pain, Neuropathic, Epilepsy
Cancer in Patients With Gabapentin (GPRD)
High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in AERS or in the…
- Conditions
- Pain, Neuropathic, Epilepsy, Renal Pelvis Cancer, Pancreatic Cancer
- Trial name
- NCT01236053
- Testing
- Gabapentin prescriptions
- Volunteers
- 2,323,608 people
- Sponsor
- GlaxoSmithKline
HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System
This is a Single-center prospective pilot trial involving up to 22 subjects. This study will assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal canal using the FDA cleared HALO Ablation…
- Trial name
- AIN (NCT01970787)
- Testing
- Radiofrequency Ablation (RFA) using the HALO Ablation System
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Medtronic - MITG
Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition
Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL
This is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
- Conditions
- Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition, AIN 2/3, HPV Infection
- Trial name
- anal HSIL HIV- (NCT05555862)
- Testing
- Artesunate
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Frantz Viral Therapeutics, LLC
Anal Cancer, Rectal Cancer
A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal
This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 participants, respectively with persistent/recurrent, loco-regional or metastatic squamous cell carcinoma…
- Trial name
- NCT02399813
- Testing
- Axalimogene filolisbac
- Where
- 10 sites in United States
- Volunteers
- 36 people
- Sponsor
- Advaxis, Inc.
Warts, Genital, Neoplasms, Anal
Efficacy, Immunogenicity, and Safety Study of V503 (9-valent Human Papillomavirus [9vHPV] Vaccine) in Japanese Males (V503-064)
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the…
- Trial name
- NCT04635423
- Testing
- V503
- Where
- 22 sites in Japan
- Volunteers
- 1,059 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC