Clinical trials: Anal Canal Cancer
Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal, Colorectal Cancer, Squamous Cell Carcinoma of the Lung
- Trial name
- NCT04429542
- Testing
- BCA101, Pembrolizumab
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 473 people
- Sponsor
- Bicara Therapeutics
Adenocarcinoma, Adenocystic Carcinoma
The Registry of Oncology Outcomes Associated With Testing and Treatment
This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation.
- Conditions
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer, Appendix Cancer
- Trial name
- ROOT (NCT04028479)
- Testing
- Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
- Where
- 2 sites in United States
- Volunteers
- 167 people
- Sponsor
- Taproot Health
Ovarian Cancer, Bladder Cancer
INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors
This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as…
- Conditions
- Ovarian Cancer, Bladder Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT04580485
- Testing
- INCB106385, INCMGA00012
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 54 people
- Sponsor
- Incyte Corporation
Cancer, All Types, Cancer of Liver
The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)
The PIONEER Initiative stands for Precision Insights On N-of-1 Ex vivo Effectiveness Research. The PIONEER Initiative is designed to provide access to functional precision medicine to any cancer patient with any tumor at any…
- Conditions
- Cancer, All Types, Cancer of Liver, Cancer of Stomach, Cancer of Head and Neck
- Trial name
- PIONEER (NCT03896958)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- SpeciCare
Solid Tumors With PTCH1 Loss-of-function Mutations
A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
This study employs a 2-stage design that aims to evaluate the efficacy and safety of ENV- 101, a potent Hedgehog (Hh) pathway inhibitor, in patients with refractory advanced solid tumors characterized by loss of function (LOF)…
- Trial name
- NCT05199584
- Testing
- ENV-101 (taladegib)
- Where
- 16 sites in United States
- Volunteers
- 20 people
- Sponsor
- Endeavor Biomedicines, Inc.
Advanced Solid Tumors, Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study of INCA 0186 in Subjects With Advanced Solid Tumors
This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when…
- Conditions
- Advanced Solid Tumors, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Gastrointestinal (GI) Malignancies
- Trial name
- NCT04989387
- Testing
- INCA00186, Retifanlimab, INCB106385
- Where
- 32 sites in United States, Austria and 4 more
- Volunteers
- 57 people
- Sponsor
- Incyte Corporation
Squamous Cell Carcinoma of Anal Canal
A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.
- Trial name
- NCT03597295
- Testing
- Retifanlimab
- Where
- 46 sites in United States, Belgium and 7 more
- Volunteers
- 94 people
- Sponsor
- Incyte Corporation
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.
Anal Intraepithelial Neoplasia (AIN), High-grade Squamous Intraepithelial Lesions (HSIL)
A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia
Assess the safety, feasibility, and patient tolerability of circumferential radiofrequency ablation (RFA) to the anal canal for patients with anal intraepithelial neoplasia (AIN).
- Trial name
- NCT02189161
- Testing
- Radiofrequency Ablation (Barrx™)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medtronic - MITG
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
Squamous Cell Carcinoma of the Anal Canal
An Early Access Program Guideline to Provide Access to Retifanlimab (INCMGA00012) Together With Carboplatin and Paclitaxel for Squamous Carcinoma of the Anal Canal (SCAC)
To provide retifanlimab, on a reactive basis, to adult patients with squamous carcinoma of the anal canal in combination with carboplatin and paclitaxel and who are considered ineligible for other therapeutic options including…
- Trial name
- NCT06910137
- Testing
- retifanlimab
- Sponsor
- Incyte Corporation
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Melanoma, Breast Carcinoma
A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity…
- Conditions
- Melanoma, Breast Carcinoma, Hepatocellular Carcinoma, Urothelial Carcinoma
- Trial name
- DUET-2 (NCT03517488)
- Testing
- XmAb20717
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Xencor, Inc.
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.
Advanced Cancer, Anal Carcinoma
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).
- Conditions
- Advanced Cancer, Anal Carcinoma, Anal Cancer, Biliary Cancer
- Trial name
- NCT02628067
- Testing
- pembrolizumab
- Volunteers
- 1,609 people
- Sponsor
- Merck Sharp & Dohme LLC
Anal Canal Squamous Cell Carcinoma
A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer
The objective of this trial is to assess anti-tumour activity of BI 754091 as monotherapy and of BI 754091 in combination with BI 836880 in patients with unresectable or metastatic squamous cell carcinoma of the anal canal who…
- Trial name
- NCT04499352
- Testing
- BI 754091, BI 836880
- Where
- South Korea
- Sponsor
- Boehringer Ingelheim