Treatment Clinical Trials for Anal Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for anal cancer treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 27
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  • Nivolumab and Ipilimumab in Treating Patients with Rare Tumors

    This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07 / 27 / 2018) 2. Epithelial tumors of major salivary glands (closed to accrual 03 / 20 / 2018) 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual) 4. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. Adenocarcinoma with variants of small intestine (closed to accrual 05 / 10 / 2018) 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10 / 17 / 2018) 7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03 / 20 / 2018) 8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible 9. Intrahepatic cholangiocarcinoma (closed to accrual 03 / 20 / 2018) 10. Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03 / 20 / 2018) 11. Sarcomatoid carcinoma of lung 12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma 13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03 / 30 / 2018) 14. Trophoblastic tumor: A) Choriocarcinoma (closed to accrual 04 / 15 / 2019) 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual 04 / 15 / 2019) 16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non-seminomatous tumor C) Teratoma with malignant transformation (closed to accrual 3 / 15 / 2019) 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 18. Squamous cell carcinoma variants of the genitourinary (GU) system 19. Spindle cell carcinoma of kidney, pelvis, ureter 20. Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07 / 27 / 2018) 21. Odontogenic malignant tumors 22. Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) 23. Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12 / 19 / 2017) 24. Pheochromocytoma, malignant 25. Paraganglioma (closed to accrual 11 / 29 / 2018) 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex 27. Desmoid tumors 28. Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09 / 19 / 2018) 29. Malignant giant cell tumors 30. Chordoma (closed to accrual 11 / 29 / 2018) 31. Adrenal cortical tumors (closed to accrual 06 / 27 / 2018) 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12 / 22 / 2017) 33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03 / 15 / 2019) 34. Adenoid cystic carcinoma (closed to accrual 02 / 06 / 2018) 35. Vulvar cancer 36. MetaPLASTIC carcinoma (of the breast) 37. Gastrointestinal stromal tumor (GIST) (closed to accrual 09 / 26 / 2018) 38. Perivascular epithelioid cell tumor (PEComa) 39. Apocrine tumors / extramammary Paget’s disease 40. Peritoneal mesothelioma 41. Basal cell carcinoma 42. Clear cell cervical cancer 43. Esthenioneuroblastoma 44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual) 45. Clear cell endometrial cancer 46. Clear cell ovarian cancer 47. Gestational trophoblastic disease (GTD) 48. Gallbladder cancer 49. Small cell carcinoma of the ovary, hypercalcemic type 50. PD-L1 amplified tumors 51. Angiosarcoma 52. High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 53). Small cell lung cancer is not eligible 53. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)
    Location: 888 locations

  • Nivolumab after Combined Modality Therapy in Treating Patients with High Risk Stage II-IIIB Anal Cancer

    This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 819 locations

  • Lower-Dose Chemoradiation in Treating Patients with Early-Stage Anal Cancer, the DECREASE Study

    This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.
    Location: 412 locations

  • Nivolumab with or without Ipilimumab in Treating Patients with Refractory Metastatic Anal Canal Cancer

    This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 45 locations

  • 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 of XmAb20717 in subjects with selected advanced solid tumors.
    Location: 16 locations

  • 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).
    Location: 8 locations

  • High-Dose-Rate Brachytherapy and Chemotherapy in Treating Patients with Locally Recurrent or Residual Rectal or Anal Cancer Undergoing Non-operative Management

    This phase I trial studies the side effects and best dose of high-dose-rate brachytherapy when given together with chemotherapy in treating patients with rectal or anal cancer that has come back or gotten worse and cannot be treated with surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. High-dose-rate (HDR) brachytherapy uses the radioactive material to deliver a high radiation dose in a short period of time to the tumor. It may also send less radiation to nearby healthy tissues and may reduce the risk of side effects. Drugs used in chemotherapy, such as capecitabine and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving HDR brachytherapy together with capecitabine or fluorouracil may kill more tumor cells.
    Location: 6 locations

  • Pembrolizumab in Treating Patients with Metastatic or Locally Advanced Anal Cancer That Cannot Be Removed by Surgery

    This phase II trial studies how well pembrolizumab works in treating patients with anal cancer that has spread to other places in the body or that has spread from its original site of growth to nearby tissues or lymph nodes and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 5 locations

  • Stereotactic Radiosurgery in Treating Patients with Oligometastatic Disease

    This phase II trial studies how well stereotactic radiosurgery works in treating patients with cancer that has spread to 5 or fewer places in the body and involves 3 or fewer organs (oligometastatic disease). Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.
    Location: 3 locations

  • Artesunate in Treating Patients with High-Grade Anal Intraepithelial Neoplasia

    This phase I trial studies the side effects and best dose of artesunate in treating patients with high-grade anal intraepithelial neoplasia. Anal intraepithelial neoplasia are precancerous cells that may or may not become a cancer in the future. Most of the changes that lead to cancer are caused by human papillomavirus (HPV). Artesunate may kill cells infected with HPV.
    Location: 2 locations

  • A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours

    The main objective of the dose-escalation part of the trial is to determine the safety and tolerability, and to determine the Maximum Tolerated Dose and / or the Recommended Phase 2 Dose (RP2D) of BI 754091 on the basis of patients with dose-limiting toxicities (DLTs) in patients with selected advanced solid malignancies. Safety and tolerability will be evaluated by monitoring the occurrence of adverse events (AEs), serious AEs (SAE), and laboratory parameter abnormalities, as well as changes to vital signs. Secondary objectives are the determination of the PK profile of BI 754091 after single and multiple doses of BI 754091, and the preliminary assessment of antitumour activity. In the dose-expansion part of the trial, the main objectives are to further assess the safety, efficacy, PK profile, and biomarkers of BI 754091 in tumours with specific tumour types and / or genetic mutations at the RP2D.
    Location: 3 locations

  • Study of SO-C101 and SO-C101in Combination With Pembro in Adult Patients With Advanced / Metastatic Solid Tumors

    A multicenter open-label phase 1 / 1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced / metastatic solid tumors
    Location: M D Anderson Cancer Center, Houston, Texas

  • Comparing Length of Treatment with Immunotherapy in Patients with Advanced Solid Tumors

    This phase III trial compares 1 year immunotherapy treatment versus continuous immunotherapy treatment beyond 1 year in patients with solid tumor that has spread to other places in the body (advanced). Immunotherapy such as pembrolizumab, nivolumab, atezolizumab, durvalumab, and avelumab are drugs given through a vein to the entire body to activate the immune system. Comparing the treatment lengths may help doctors determine the ideal length of time for treatment with immunotherapy in patients with solid tumors.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas

    This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Papaverine Hydrochloride and Stereotactic Body Radiation Therapy in Treating Patients with Non-small Cell Lung Cancer or Lung Metastases

    This phase I trial studies the side effects and how well papaverine hydrochloride and stereotactic radiation therapy body (SBRT) work in treating patients with non-small cell lung cancer or cancer that has spread to the lung (lung metastases). Papaverine hydrochloride may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving papaverine hydrochloride with SBRT may work in treating patients with non-small cell lung cancer or lung metastases.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • LET-IMPT and Standard Chemotherapy in Treating Patients with Newly Diagnosed Stage I-III Anal Canal Squamous Cell Cancer

    This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer. LET-IMPT is a type of radiation therapy that uses high energy proton “beamlets” to “paint” the radiation dose into the target and may help to kill tumor cells and shrink tumors. Giving LET-IMPT and standard chemotherapy may work better in treating patients with anal canal squamous cell cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

  • VGX-3100 and Electroporation in Treating Patients with HIV-Positive High-Grade Anal Lesions

    This phase II trials studies how well human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation work in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body’s cells take in the drug to strengthen your immune system’s response. Giving VGX-3100 and electroporation together may work better in treating patients with high-grad anal lesions.
    Location: 2 locations

  • DNA Plasmid-encoding Interleukin-12 / HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients with Recurrent or Metastatic Human Papillomavirus Associated Cancers

    This phase II trial studies how well deoxyribonucleic acid (DNA) plasmid-encoding interleukin-12 / human papillomavirus (HPV) DNA plasmids therapeutic vaccine INO-3112 and durvalumab work in treating patients with human papillomavirus associated cancers that have come back or spread to other places in the body. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving DNA plasmid-encoding interleukin-12 / HPV DNA plasmids therapeutic vaccine INO-3112 and durvalumab may work better in treating patients with human papillomavirus associated cancers.
    Location: M D Anderson Cancer Center, Houston, Texas

  • M7824 in Subjects With HPV Associated Malignancies

    Background: In the United States, each year there are more than 30,000 cases of human papillomavirus (HPV) associated cancers. Some of these cancers are often incurable and are not improved by standard therapies. Researchers want to see if a new drug M7824, which targets and blocks a pathway that prevents the immune system from effectively fighting the cancer can shrink tumors in people with some HPV cancers. Objectives: To see if the drug M7824 causes tumors to shrink. Eligibility: Adults age 18 and older who have a cancer associated with HPV infection. Design: Participants will be screened with medical history and physical exam. They will review their symptoms and how they perform normal activities. They will have body scans. They will give blood and urine samples. They will have a sample of their tumor tissue taken if one is not available. Participants will have an electrocardiogram to evaluate their heart. Then they will get the study drug through a thin tube in an arm vein. Participants will get the drug every 2 weeks for 26 times (1 year). This is 1 course. After the course, participants will be monitored but will not take the study drug. If their condition gets worse, they will start another course with the drug. This process can be repeated as many times as needed. Treatment will stop if the participant has bad side effects or the drug stops working. Throughout the study, participants will repeat some or all the screening tests. After participants stop taking the drug, they will have a follow-up visit and repeat some screening tests. They will get periodic follow-up phone calls. ...
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • MnSOD Mimetic BMX-001 in Treating Patients with Anal Cancer Undergoing Radiation Therapy and Chemotherapy

    This phase I trial studies the best dose of MnSOD mimetic BMX-001 to reduce side effects in patients with anal cancer undergoing radiation therapy and chemotherapy. Chemoprotective drugs, such as BMX-001, may protect normal cells from the side effects of chemotherapy while enhancing tumor killing.
    Location: University of Nebraska Medical Center, Omaha, Nebraska

  • PEN-866 in Patients With Advanced Solid Malignancies

    Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1 / 2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
    Location: University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma

  • Atezolizumab and Bevacizumab in Treating Patients with Rare Solid Tumors

    This phase II trial studies how well atezolizumab and bevacizumab work in treating patients with rare solid tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Photodynamic Therapy, Gliolan, and Vitamin D3 for the Treatment of Carcinoma In-situ, High-Grade Anal Dyplasia, or Microinvasive Anal Cancer

    This phase I trial studies the side effects and best dose of the light used in photodynamic therapy and how well it works with Gliolan and vitamin D3 in the treatment of patients with carcinoma in-situ (tumors that may become cancer), high-grade anal dysplasia, or microinvasive anal cancer. Photodynamic therapy uses a drug, such as Gliolan, that becomes active when it is exposed to light. The activated drug may kill tumor cells. Vitamin D3 is a type of steroid hormone that may help enhance or restore the immune system after undergoing PDT. It is not yet known if photodynamic therapy, Gliolan, and vitamin D3 may work better in treating patients with carcinoma in-situ, high-grade anal dysplasia, or microinvasive anal cancer.
    Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania

  • A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer

    The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1 / PD-L1 bispecific antibody, in participants with advanced solid tumors.
    Location: See Clinical Trials.gov

  • Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

    Background: More than 30,000 cases of human papillomavirus (HPV) associated cancers occur annually in the United States. When these cancers spread, they do not respond well to standard treatments and are often incurable. Researchers want to see if a mix of drugs can help. Objective: To learn if a mix of immunotherapy drugs can shrink tumors in people with HPV associated cancers. Eligibility: People ages 18 and older with locally advanced or metastatic HPV associated cancer, such as cervical cancers; P16+ oropharyngeal cancers; anal cancers; vulvar, vaginal, penile, and squamous cell rectal cancers; or other locally advanced or metastatic solid tumors (e.g., lung, esophagus) that are known HPV+ cancers Design: Participants will be screened with: - medical history - disease confirmation (or tumor biopsy) - physical exam - body scans (CT, MRI, and / or nuclear) - blood tests - electrocardiogram (to measure the electrical activity of the heart) - urine tests. Participants will get PDS0101 injected under the skin every 4 weeks for 6 doses. Then they will get it every 3 months for 2 doses. Participants will get M7824 by intravenous infusion every 2 weeks. For this, a needle is inserted into a vein. The drug is given over a 1-hour period. Participants will get NHS-IL12 injected under the skin every 4 weeks. Participants will get the study drugs for up to 1 year. They will visit the NIH every 2 weeks. They will repeat the screening tests during the study. About 28 days after treatment ends, participants will have a follow-up visit or telephone call. Then they will be contacted every 3 months for 1 year, and then every 6 months after that, for the rest of their life....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland


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