Anal Cancer

Researchers are evaluating the safety and effects of Papillex4, a dietary supplement, on the regression of abnormal cervical cells caused by HPV in women diagnosed with cervical intraepithelial neoplasia (CIN) grades 1 or 2. The main goal is to see if Papillex4 leads to a greater improvement in cervical cell abnormalities compared to a placebo by day 180. Participants will take either Papillex4 or a placebo twice daily for 180 days. Papillex4 contains vitamins, minerals, plant extracts, and other natural substances. Both groups will follow the same dosing schedule with two capsules taken with the first and last meals each day. The study design is randomized and quadruple-blinded, meaning neither participants nor researchers know who receives Papillex4 or placebo. During the study, participants will undergo clinical visits, complete questionnaires, and have cervical cell assessments including PAP smears and HPV tests. Some may have colonoscopy if applicable. Researchers will measure changes in cervical cell abnormalities, HPV clearance, immune markers, micronutrient status, symptom scores, quality of life, and monitor safety events over 180 to 360 days. Participants are expected to maintain their usual lifestyle habits and complete all study activities and visits.

Researchers are conducting an observational study to understand prognostic and predictive factors affecting patients with anal squamous cell carcinoma (CCA), both with and without HIV infection. The study seeks to describe patient profiles worldwide, including factors such as CD4 counts, duration of HIV infection, viral load, AIDS diagnosis, geographic treatment regions, clinical staging, medication interactions, comorbidities, use and duration of highly active antiretroviral therapy (HAART), and radiotherapy types. It aims to compare clinical outcomes between patients living with HIV and those without. Participants include patients diagnosed with anal squamous cell carcinoma, with or without HIV infection. The study groups are divided based on HIV status. Data collected will reflect real-world treatment modalities, including conventional 3D radiotherapy versus Intensity Modulated Radiotherapy (IMRT), and responses to specific chemotherapy regimens. There are no interventional treatments assigned by the study, as this is an observational record. Participants will be followed to assess key outcomes such as median disease-free survival over three years, complete clinical response at six months, and overall survival from treatment start to death from any cause within three years. Researchers will gather data on treatment details, clinical staging, medication use, and other health factors. The study aims to provide comprehensive insights into how HIV status and related factors influence anal cancer treatment outcomes and survival over time.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of HS-20110 combination therapies in patients with advanced colorectal cancer. This multicenter, open-label Phase Ib/II study uses a "Rolling 6" design for dose escalation in Phase Ib, followed by Phase II to further assess these treatments in patients with metastatic colorectal cancer (mCRC). The study includes three treatment groups receiving different HS-20110 combinations: one with Bevacizumab and 5-FU/leucovorin every two weeks, another with Bevacizumab, Oxaliplatin, and 5-FU/leucovorin every two weeks, and a third with Bevacizumab, Oxaliplatin, and Capecitabine every three weeks. The treatments are given via intravenous infusion in cycles, with doses adjusted during the study. Participants will be monitored for safety, side effects, drug levels, and response to treatment. Assessments include tumor response using RECIST v1.1 criteria, adverse events, antibody formation against HS-20110, and survival outcomes. Monitoring continues from the first dose until up to three years after the last dose. The study aims to determine the best dose and evaluate the impact on disease control and patient survival over time.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus (HPV) vaccine in Chinese women aged 18 to 45 years. This Phase III clinical trial involves 13,500 women divided into three age groups to assess the vaccine's ability to prevent HPV infections and related cervical lesions. Participants are randomized into experimental and placebo groups to compare outcomes. The trial administers three doses of either the HPV vaccine or a placebo via intramuscular injections into the upper arm deltoid muscle, scheduled at 0, 2, and 6 months. The study uses a double-blind design to ensure unbiased results. The vaccine targets multiple HPV types associated with cervical cancer and related conditions. Participants will undergo follow-up visits including gynecological examinations, pregnancy testing, and monitoring for adverse events. Researchers will measure the incidence of cervical intraepithelial neoplasia (CIN) and HPV-related lesions, as well as antibody responses at multiple time points after vaccination. The trial includes long-term monitoring up to six years to evaluate vaccine safety and effectiveness.

Researchers are studying EVOLVE104 in adults with advanced urothelial and squamous cell carcinomas who have either received standard treatments without success, declined those treatments, or were ineligible for them. This phase 1a/1b clinical trial aims to assess the safety, tolerability, and how the body processes EVOLVE104, a drug given by intravenous infusion, in participants with various advanced solid tumors including bladder, lung, esophageal, tongue, skin, and anogenital squamous cell cancers. The study includes a dose-escalation phase followed by a dose-expansion phase with two cohorts, depending on initial safety and effectiveness data. Participants will receive EVOLVE104 in different dose levels during the phase 1a dose-escalation stage, with doses adjusted to find the maximum tolerated dose and recommended phase 2 dose. Phase 1b will include up to two expansion cohorts with doses based on findings from phase 1a. Treatment continues until disease progression, adverse events, participant or investigator decision to stop, withdrawal of consent, or death, with an expected duration of about 10 months. During the study, participants undergo regular safety evaluations, including monitoring for treatment-emergent adverse events and dose-limiting toxicities. Pharmacokinetics and pharmacodynamics assessments occur each 28-day cycle with blood samples taken before and after dosing. Tumor measurements are done by CT or MRI scans. Researchers also monitor anti-drug antibodies and track efficacy signals. Participants must provide tumor biopsies and meet specific health criteria to join. The study may last up to 10 months per participant, with ongoing safety and response assessments throughout.

Researchers are evaluating the effectiveness of FOLFIRI chemotherapy with or without Bevacizumab compared to Irinotecan (CPT-11) with or without Bevacizumab as a second-line treatment for patients with metastatic colorectal cancer. This Phase III study aims to determine whether overall survival with FOLFIRI is not worse than with Irinotecan. Key goals include assessing progression-free survival, overall survival, time to treatment failure, response rates, disease control, and safety. The study involves two experimental treatment groups. One group receives Bevacizumab intravenously on day 1 of a two-week cycle, combined with CPT-11, l-LV (or dl-LV), and 5-FU given as both a bolus and continuous infusion over 46 hours. The other group receives Bevacizumab with CPT-11 only, also on day 1 of a two-week cycle. These infusions are repeated every two weeks during the treatment period. Participants will undergo regular monitoring including assessments of tumor progression and response at scheduled intervals, laboratory tests to check organ function, and recording of any adverse events up to 24 weeks. The primary outcome, progression-free survival, is tracked until 1.5 years after the last patient is enrolled. Secondary outcomes such as overall survival and time to treatment failure are also measured during this period. This study requires informed consent and includes safety follow-up to ensure participant well-being throughout the trial.

This research aims to study the immune response to the nonavalent HPV (9vHPV) vaccine in women living with HIV (WLWH), a group particularly vulnerable to HPV and cervical cancer. There is limited data on reduced-dose schedules of the 9vHPV vaccine in this population, which is important as the previously used quadrivalent HPV vaccine has been discontinued. The study seeks to inform global strategies for cervical cancer elimination by evaluating different dosing schedules in WLWH aged 18 to 45 years. Participants will be randomly assigned to one of two groups: one group will receive three doses of the 9vHPV vaccine following the routine schedule at 0, 2, and 6 months, while the other group will receive two doses at 0 and 6 months, with a third dose at month 12. This design follows current recommendations and allows comparison of immune responses between the routine and extended dosing schedules. During the two-year follow-up, participants will undergo regular assessments to measure immune responses, specifically anti-HPV16/18 antibody levels at months 7 and 24. Researchers will also evaluate vaccine safety, effectiveness, and attitudes toward self-collected HPV samples. Surveys will assess vaccine acceptability and comfort. The study includes monitoring for adverse events and aims to provide data to improve HPV vaccination programs for WLWH globally.

Researchers are evaluating whether using lower doses of radiation can reduce side effects when combined with standard chemotherapy in people with HPV-positive throat cancer. This Phase 2 study focuses on patients with hypoxia negative human papilloma virus (HPV) associated oropharyngeal carcinoma, aiming to improve treatment tolerability while maintaining effectiveness. Chemotherapy drugs involved include cisplatin, carboplatin, 5-fluorouracil (5-FU), paclitaxel, and Abraxane (albumin-bound paclitaxel). Participants are assigned to one of four cohorts based on their specific clinical characteristics. Treatments include radiation over three weeks with a total dose of 30 Gy in 2 Gy fractions, combined with chemotherapy regimens varying by cohort. For example, Cohort B receives carboplatin and paclitaxel starting the same week as radiation; Cohort C includes induction chemotherapy before radiation; and Cohort D focuses on early-stage cases. The study also uses 18F-FMISO PET/CT scans for diagnostic imaging before and during treatment to guide therapy. During the study, participants undergo regular assessments including imaging scans, blood tests to evaluate blood counts and organ function, and clinical evaluations to monitor disease status and side effects. Researchers will measure the number of participants experiencing locoregional cancer recurrence over 2 years. Participants must provide informed consent and comply with study procedures, including MRI scans unless contraindicated. The total participation duration varies depending on treatment and follow-up schedules.

Researchers are evaluating SPX-303, a bispecific antibody targeting LILRB2 and PD-L1, in patients with advanced solid tumors who have progressed after prior treatments and are not eligible or decline other options. This open-label Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SPX-303, including identifying the maximum tolerated dose or maximum administered dose. The study consists of two parts: Part 1 is a dose escalation and safety expansion phase where SPX-303 is given intravenously every 3 weeks to patients with measurable disease. Part 2 focuses on dose expansion in specific solid tumor types using the recommended Phase 2 dose established in Part 1 to further evaluate anti-tumor activity. Both parts involve close monitoring of treatment effects and side effects. Participants will undergo regular visits for assessments including monitoring for dose-limiting toxicities, adverse events, response rates, disease control, progression-free survival, and drug levels in the body. Safety evaluations will continue for several years, with treatment-related adverse events tracked for up to 3.5 years. The study duration and follow-up periods vary by participant and study phase.

Researchers are evaluating whether monitoring HPV circulating tumor DNA (ctDNA) levels can effectively detect the risk of cancer returning in people with HPV-associated oropharynx cancer (HPV-OPC) who have recently undergone or are scheduled for surgery. The study aims to determine if this monitoring can guide decisions about radiation therapy and chemotherapy, potentially allowing for delayed or reduced treatment. This is a Phase II trial sponsored by Memorial Sloan Kettering Cancer Center. Participants are divided into two groups. In Arm A, those with rising HPV ctDNA levels after surgery may have radiation therapy delayed until ctDNA becomes detectable, with radiation doses of 50-60 Gy planned. In Arm B, patients typically needing 6 to 6.5 weeks of chemoradiation may receive a shorter, 3-week course of radiation with concurrent chemotherapy. Both arms involve detailed imaging with FDG PET/CT scans for treatment planning and to check for cancer spread. Throughout the study, participants will undergo blood tests to measure HPV ctDNA, imaging scans, and complete questionnaires assessing quality of life and financial impact. Researchers will track progression-free survival over two years, along with detailed monitoring of treatment effects. Treatment is personalized based on ctDNA results and pathology findings, with ongoing assessments for safety and effectiveness during follow-up visits.