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| Name | Class |
|---|---|
| Seres Therapeutics, Inc. | INDUSTRY |
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This study is designed to evaluate the safety and tolerability of treatment with oral microbiome study intervention (SER-401) or matching placebo in combination with anti-programmed cell death 1 (anti-PD-1) therapy (nivolumab) in participants with unresectable or metastatic melanoma. The study also intends to assess clinical outcomes, the impact of microbiome study intervention administration on the microbiome profile, and its association with clinical and immunological outcomes.
This is a Phase 1b, multicenter, randomized, placebo-controlled, blinded study in adult participants with anti-PD-1 therapy naïve, unresectable or metastatic melanoma to evaluate the safety and tolerability of SER-401, or matching placebo in combination with anti-PD-1 therapy (nivolumab). Prior to initiating microbiome study intervention and nivolumab, participants will undergo an antibiotic or antibiotic placebo treatment lead-in to prime the gut microbiome for engraftment of the oral microbiome study intervention. Study intervention groups will be assessed for safety, changes in the microbiome, changes in the percentage of tumoral CD8 T cells, and antitumor activity. Participants must have measurable disease that can be biopsied and consent to baseline and on-treatment biopsies, as well as stool and blood biomarker collection throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SER-401 Matching Placebo/ Nivolumab | Placebo Comparator | Participants will undergo a 4-day lead-in pretreatment with antibiotic placebo, then matching placebo for SER-401 and nivolumab (480 mg) treatment. |
|
| SER-401/ Nivolumab | Experimental | Participants will undergo a 4-day lead-in pretreatment with antibiotic (vancomycin) to prime the gut microbiome for engraftment of the oral microbiome study intervention, then SER-401 and nivolumab treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo for antibiotic | Drug | Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Adverse Events (AEs) | Investigators recorded AEs during each participant interaction. Symptoms were evaluated by the Investigator using the CTCAE version 5.0. This system grades AEs on a 1 to 5 scale: Grades 1 and 2 indicate mild to moderate events; Grade 3 denotes severe events; Grades 4 and 5 signify life-threatening or fatal outcomes. A treatment-emergent adverse event (TEAE) is defined as any event that either occurs after the initiation of study intervention, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, regardless of its relation to the intervention. Adverse events deemed 'Possibly', 'Probably', or 'Definitely' related to the intervention were labeled as treatment-related adverse events (TRAE). | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Number of Newly Appearing Spore-forming Species | Engraftment was defined as the number of spore-forming species detected in SER-401 that were absent in participant baseline samples, and present post-microbiome-treatment, also referred to as newly appearing dose species. | Up to 2 years |
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Inclusion Criteria:
Participant must be willing to provide a baseline stool sample.
Histologically-confirmed Stage IV cutaneous melanoma or Stage III cutaneous, acral or mucosal melanoma that is judged inoperable. Participants with a history of uveal melanoma are not eligible.
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1; ie, defined as at least 1 lesion that can be accurately measured in at least 1 dimension [longest diameter to be recorded] with a minimum size of ≥ 10 mm by computerized tomography [CT] scan or caliper measurement on clinical exam or ≥ 20 mm by chest X-ray).
i. Participants must be willing to undergo a newly-obtained core needle or incisional biopsy at baseline (prior to antibiotic or antibiotic placebo administration). Fine needle aspiration is not acceptable.
Participants must be willing to undergo tumor biopsy on treatment.
Prior adjuvant or neoadjuvant melanoma therapy is permitted if completed at least 6 weeks prior to randomization and all related AEs have either returned to baseline or stabilized.
Exclusion Criteria:
Participants who require hemodialysis.
Participants with a history of another cancer in the last 5 years, except for: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; c) localized prostate cancer not requiring systemic therapy; and c) other primary tumors with no known active disease present that, in the opinion of the Investigator and the Sponsor, will not affect participant outcome in the setting of the current diagnosis.
Any known, untreated brain metastases. Participants with brain metastases are eligible if these have been treated, and provided:
Prior checkpoint inhibitor therapy with anti-PD-1 or anti-PD-L1 in the adjuvant setting.
a. Exception: Participants with stage 3 or 4 cutaneous melanoma status post-resection who have received up to one year of adjuvant anti-PD-1 therapy who have recurred > 6 months after their last dose of anti-PD-1 therapy are eligible.
Other prior systemic treatment (ie, anticancer chemotherapy, immunotherapy, or investigational agents) for unresectable or metastatic melanoma EXCEPT:
History of active inflammatory bowel disease (eg, active Crohn's disease or ulcerative colitis) with diarrhea OR major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment (ie, signed informed consent for the study), OR any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, ie, restrictive procedures such as banding, are permitted).
Any diagnosis of autoimmune disease. Participants with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, adrenal insufficiency on replacement dose steroids, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
a. Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study intervention administration or has a contrast allergy requiring premedication with corticosteroids. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (ie, bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan.
a. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Has a transplanted organ or has undergone allogeneic bone marrow transplant.
Has received a live vaccine within 30 days prior to first dose. Participants must not receive live, attended influenza vaccine (eg, FluMist) within 30 days prior to Cycle 1, Day 1 or at any time during the study and 100 days after last dose of nivolumab.
Has used antibiotics within 30 days prior to randomization or has planned or required need for antibiotic prophylaxis for more than 24 consecutive hours during the course of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Parker Institute for Cancer Immunotherapy | Parker Institute for Cancer Immunotherapy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26034755 | Background | Alang N, Kelly CR. Weight gain after fecal microbiota transplantation. Open Forum Infect Dis. 2015 Feb 4;2(1):ofv004. doi: 10.1093/ofid/ofv004. eCollection 2015 Jan. | |
| 20368546 | Background | Balch CM, Gershenwald JE, Soong SJ, Thompson JF, Ding S, Byrd DR, Cascinelli N, Cochran AJ, Coit DG, Eggermont AM, Johnson T, Kirkwood JM, Leong SP, McMasters KM, Mihm MC Jr, Morton DL, Ross MI, Sondak VK. Multivariate analysis of prognostic factors among 2,313 patients with stage III melanoma: comparison of nodal micrometastases versus macrometastases. J Clin Oncol. 2010 May 10;28(14):2452-9. doi: 10.1200/JCO.2009.27.1627. Epub 2010 Apr 5. |
| Label | URL |
|---|---|
| NCT02437487: SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | SER-401 Matching Placebo/ Nivolumab | Participants will undergo a 4-day lead-in pretreatment with antibiotic placebo, then matching placebo for SER-401 and nivolumab (480 mg) treatment. Placebo for antibiotic: Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout. Nivolumab: Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks. Matching Placebo for SER-401: Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2020 | Sep 22, 2022 |
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Participants will be randomly assigned in a 2:1 ratio to oral microbiome study intervention or matching placebo. Nivolumab will be administered open-label as standard of care to all groups. Investigators, site personnel, and participants will remain blinded to the assignment of microbiome study intervention throughout the course of the study. Select Sponsor personnel, including but not limited to the Medical Monitor, Clinical Scientists, Biostatistician, and Patient Safety, will be unblinded to treatment assignment for ongoing safety monitoring.
| Vancomycin pretreatment | Drug | Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout. |
|
| Nivolumab | Drug | Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks. |
|
|
| Matching Placebo for SER-401 | Drug | Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. |
|
| SER-401 | Drug | Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. |
|
| Objective Response Rate (ORR) |
Objective Response Rate (ORR) is defined as the proportion of participants who attain a best overall response of complete response (CR; disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions), as determined by RECIST version 1.1. Confirmation of response by a repeat tumor assessment is not required. |
| Up to week 52 |
| Disease Control Rate (DCR) | Defined as CR, PR, or stable disease (SD) for ≥ 24 weeks as best response by RECIST v1.1. | Up to week 52 |
| Progression-free Survival (PFS) | Defined as the time from randomization to date of first documented progression of disease, date of death due to any cause, or date of most recent participant contact that documented progression-free status | Up to 2 years |
| Overall Survival (OS) | Defined as the time from randomization until death or last contact if still alive at the time of final data collection (after completion of anti-PD-1 therapy). | Up to 2 years |
| Duration of Response | Defined as time from date of documented CR or PR to date of first documented progression of disease, date of death due to any cause, or date of most recent participant contact that documented response (ie, scan date). | Up to 2 years |
| Absolute Change in the Percentage of CD8 Cells in Tumor Tissue From Baseline at Cycle 2. | Absolute change in the percentage of CD8 cells in tumor tissue from baseline at Cycle 2. | At cycle 2 (each cycle is 28 days) |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
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| 29617739 | Background | Dubberke ER, Lee CH, Orenstein R, Khanna S, Hecht G, Gerding DN. Results From a Randomized, Placebo-Controlled Clinical Trial of a RBX2660-A Microbiota-Based Drug for the Prevention of Recurrent Clostridium difficile Infection. Clin Infect Dis. 2018 Sep 28;67(8):1198-1204. doi: 10.1093/cid/ciy259. |
| 19097774 | Background | Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. |
| 22018062 | Background | Ekwueme DU, Guy GP Jr, Li C, Rim SH, Parelkar P, Chen SC. The health burden and economic costs of cutaneous melanoma mortality by race/ethnicity-United States, 2000 to 2006. J Am Acad Dermatol. 2011 Nov;65(5 Suppl 1):S133-43. doi: 10.1016/j.jaad.2011.04.036. |
| 29097493 | Background | Gopalakrishnan V, Spencer CN, Nezi L, Reuben A, Andrews MC, Karpinets TV, Prieto PA, Vicente D, Hoffman K, Wei SC, Cogdill AP, Zhao L, Hudgens CW, Hutchinson DS, Manzo T, Petaccia de Macedo M, Cotechini T, Kumar T, Chen WS, Reddy SM, Szczepaniak Sloane R, Galloway-Pena J, Jiang H, Chen PL, Shpall EJ, Rezvani K, Alousi AM, Chemaly RF, Shelburne S, Vence LM, Okhuysen PC, Jensen VB, Swennes AG, McAllister F, Marcelo Riquelme Sanchez E, Zhang Y, Le Chatelier E, Zitvogel L, Pons N, Austin-Breneman JL, Haydu LE, Burton EM, Gardner JM, Sirmans E, Hu J, Lazar AJ, Tsujikawa T, Diab A, Tawbi H, Glitza IC, Hwu WJ, Patel SP, Woodman SE, Amaria RN, Davies MA, Gershenwald JE, Hwu P, Lee JE, Zhang J, Coussens LM, Cooper ZA, Futreal PA, Daniel CR, Ajami NJ, Petrosino JF, Tetzlaff MT, Sharma P, Allison JP, Jenq RR, Wargo JA. Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients. Science. 2018 Jan 5;359(6371):97-103. doi: 10.1126/science.aan4236. Epub 2017 Nov 2. |
| 23333862 | Background | Hamilton MJ, Weingarden AR, Unno T, Khoruts A, Sadowsky MJ. High-throughput DNA sequence analysis reveals stable engraftment of gut microbiota following transplantation of previously frozen fecal bacteria. Gut Microbes. 2013 Mar-Apr;4(2):125-35. doi: 10.4161/gmic.23571. Epub 2013 Jan 18. |
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| 26027431 | Background | Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31. |
| 26757463 | Background | Lee CH, Steiner T, Petrof EO, Smieja M, Roscoe D, Nematallah A, Weese JS, Collins S, Moayyedi P, Crowther M, Ropeleski MJ, Jayaratne P, Higgins D, Li Y, Rau NV, Kim PT. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):142-9. doi: 10.1001/jama.2015.18098. |
| 27974040 | Background | Lynch SV, Pedersen O. The Human Intestinal Microbiome in Health and Disease. N Engl J Med. 2016 Dec 15;375(24):2369-2379. doi: 10.1056/NEJMra1600266. No abstract available. |
| 29302014 | Background | Matson V, Fessler J, Bao R, Chongsuwat T, Zha Y, Alegre ML, Luke JJ, Gajewski TF. The commensal microbiome is associated with anti-PD-1 efficacy in metastatic melanoma patients. Science. 2018 Jan 5;359(6371):104-108. doi: 10.1126/science.aao3290. |
| 29562266 | Background | McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, Dubberke ER, Garey KW, Gould CV, Kelly C, Loo V, Shaklee Sammons J, Sandora TJ, Wilcox MH. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):987-994. doi: 10.1093/cid/ciy149. |
| 25857665 | Background | Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7. |
| 28214091 | Background | Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15. |
| 27461176 | Background | Pigneur B, Sokol H. Fecal microbiota transplantation in inflammatory bowel disease: the quest for the holy grail. Mucosal Immunol. 2016 Nov;9(6):1360-1365. doi: 10.1038/mi.2016.67. Epub 2016 Jul 27. |
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| 26541606 | Background | Sivan A, Corrales L, Hubert N, Williams JB, Aquino-Michaels K, Earley ZM, Benyamin FW, Lei YM, Jabri B, Alegre ML, Chang EB, Gajewski TF. Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy. Science. 2015 Nov 27;350(6264):1084-9. doi: 10.1126/science.aac4255. Epub 2015 Nov 5. |
| 27232110 | Background | Tripp MK, Watson M, Balk SJ, Swetter SM, Gershenwald JE. State of the science on prevention and screening to reduce melanoma incidence and mortality: The time is now. CA Cancer J Clin. 2016 Nov 12;66(6):460-480. doi: 10.3322/caac.21352. Epub 2016 May 27. |
| 26519463 | Background | Vermeire S, Joossens M, Verbeke K, Wang J, Machiels K, Sabino J, Ferrante M, Van Assche G, Rutgeerts P, Raes J. Donor Species Richness Determines Faecal Microbiota Transplantation Success in Inflammatory Bowel Disease. J Crohns Colitis. 2016 Apr;10(4):387-94. doi: 10.1093/ecco-jcc/jjv203. Epub 2015 Oct 29. |
| 27529553 | Background | Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016. |
| 25825673 | Background | Weingarden A, Gonzalez A, Vazquez-Baeza Y, Weiss S, Humphry G, Berg-Lyons D, Knights D, Unno T, Bobr A, Kang J, Khoruts A, Knight R, Sadowsky MJ. Dynamic changes in short- and long-term bacterial composition following fecal microbiota transplantation for recurrent Clostridium difficile infection. Microbiome. 2015 Mar 30;3:10. doi: 10.1186/s40168-015-0070-0. eCollection 2015. |
| 19934295 | Background | Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412-20. doi: 10.1158/1078-0432.CCR-09-1624. Epub 2009 Nov 24. |
| 27609178 | Background | Youngster I, Mahabamunuge J, Systrom HK, Sauk J, Khalili H, Levin J, Kaplan JL, Hohmann EL. Oral, frozen fecal microbiota transplant (FMT) capsules for recurrent Clostridium difficile infection. BMC Med. 2016 Sep 9;14(1):134. doi: 10.1186/s12916-016-0680-9. |
| NCT02530385: Fecal Microbiota Transplant for Obesity and Metabolism | View source |
| NCT02618187: A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER- 287 in Subjects With Mild-to-Moderate Ulcerative Colitis Patients | View source |
| NCT03341143: Fecal Microbiota Transplant (FMT) in Melanoma Patients | View source |
| NCT03353402: Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy | View source |
| NCT03637803: MRx0518 and Pembrolizumab Combination Study | View source |
| Opdivo (nivolumab) US Prescribing Information (USPI), Aug-2018 | View source |
| FG001 | SER-401/ Nivolumab | Participants will undergo a 4-day lead-in pretreatment with antibiotic (vancomycin) to prime the gut microbiome for engraftment of the oral microbiome study intervention, then SER-401 and nivolumab treatment. Vancomycin pretreatment: Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout. Nivolumab: Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks. SER-401: Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SER-401 Matching Placebo/ Nivolumab | Participants will undergo a 4-day lead-in pretreatment with antibiotic placebo, then matching placebo for SER-401 and nivolumab (480 mg) treatment. Placebo for antibiotic: Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout. Nivolumab: Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks. Matching Placebo for SER-401: Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. |
| BG001 | SER-401/ Nivolumab | Participants will undergo a 4-day lead-in pretreatment with antibiotic (vancomycin) to prime the gut microbiome for engraftment of the oral microbiome study intervention, then SER-401 and nivolumab treatment. Vancomycin pretreatment: Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout. Nivolumab: Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks. SER-401: Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ruminococcaceae abundance-based metric at Screening | Stool samples were required at screening to assess fecal microbiome composition of the Ruminococcaceae abundance-based metric (high, low).The test for Ruminococcaceae is a laboratory developed test. It is not an FDA-approved device, and its use is investigational. Quantitative polymerase chain reaction (qPCR) on DNA extracted from stool was performed and the Ruminococcaceae abundance-based metric was determined. | Count of Participants | Participants |
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| ECOG Performance Score at Screening | The ECOG (Eastern Cooperative Oncology Group) performance status is a widely-used scale to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine the appropriate treatment and prognosis. Here is a brief description of the ECOG performance status:
| Count of Participants | Participants |
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| Cancer Stage at Initial Diagnosis | The stage of cancer at initial diagnosis provides vital information about the extent of cancer in the body and is pivotal for prognosis and treatment decisions. Cancer stages typically range from stage 0 (in situ, localized growth) to stage IV (advanced cancer with distant metastasis). | Count of Participants | Participants |
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| Cancer Stage at Enrollment | The stage of cancer at study enrollment provides vital information about the extent of cancer in the body and is pivotal for prognosis and treatment decisions. Cancer stages typically range from stage 0 (in situ, localized growth) to stage IV (advanced cancer with distant metastasis). Patients for this study needed to have histologically-confirmed Stage IV cutaneous melanoma or Stage III cutaneous, acral or mucosal melanoma that is judged inoperable by the treating physician. | Count of Participants | Participants |
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| Melanoma Subtype | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Adverse Events (AEs) | Investigators recorded AEs during each participant interaction. Symptoms were evaluated by the Investigator using the CTCAE version 5.0. This system grades AEs on a 1 to 5 scale: Grades 1 and 2 indicate mild to moderate events; Grade 3 denotes severe events; Grades 4 and 5 signify life-threatening or fatal outcomes. A treatment-emergent adverse event (TEAE) is defined as any event that either occurs after the initiation of study intervention, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, regardless of its relation to the intervention. Adverse events deemed 'Possibly', 'Probably', or 'Definitely' related to the intervention were labeled as treatment-related adverse events (TRAE). | Safety Population is defined as all participants who received at least 1 dose of any study intervention | Posted | Count of Participants | Participants | Up to 2 years |
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| Secondary | Mean Change From Baseline in the Number of Newly Appearing Spore-forming Species | Engraftment was defined as the number of spore-forming species detected in SER-401 that were absent in participant baseline samples, and present post-microbiome-treatment, also referred to as newly appearing dose species. | Participants were excluded from analysis at a specific time point if a stool sample was not collected or there was insufficient material available to run the assay. | Posted | Mean | Standard Deviation | spore-forming species | Up to 2 years |
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| Secondary | Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the proportion of participants who attain a best overall response of complete response (CR; disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions), as determined by RECIST version 1.1. Confirmation of response by a repeat tumor assessment is not required. | Posted | Count of Participants | Participants | Up to week 52 |
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| Secondary | Disease Control Rate (DCR) | Defined as CR, PR, or stable disease (SD) for ≥ 24 weeks as best response by RECIST v1.1. | Posted | Count of Participants | Participants | Up to week 52 |
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| Secondary | Progression-free Survival (PFS) | Defined as the time from randomization to date of first documented progression of disease, date of death due to any cause, or date of most recent participant contact that documented progression-free status | Posted | Median | 95% Confidence Interval | month | Up to 2 years |
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| Secondary | Overall Survival (OS) | Defined as the time from randomization until death or last contact if still alive at the time of final data collection (after completion of anti-PD-1 therapy). | Posted | Median | 95% Confidence Interval | month | Up to 2 years |
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| Secondary | Duration of Response | Defined as time from date of documented CR or PR to date of first documented progression of disease, date of death due to any cause, or date of most recent participant contact that documented response (ie, scan date). | The overall number of participants evaluated for duration of response includes only those who achieved a complete (CR) or partial response (PR) as per RECIST v1.1. | Posted | Median | 95% Confidence Interval | month | Up to 2 years |
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| Secondary | Absolute Change in the Percentage of CD8 Cells in Tumor Tissue From Baseline at Cycle 2. | Absolute change in the percentage of CD8 cells in tumor tissue from baseline at Cycle 2. | Only participants with available CD8 values at both baseline at Cycle 2 are included in the analysis. | Posted | Median | Full Range | percentage of CD8 cells | At cycle 2 (each cycle is 28 days) |
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All AEs were collected from the start of the study intervention until 100 days after the last dose of the study intervention, up to 2 years. Deaths were collected up to 2 years from the initiation of study intervention.
Serious Adverse Events and Other (Not Including Serious) Adverse Events include both treatment-related and non-treatment-related events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SER-401 Matching Placebo/ Nivolumab | Participants will undergo a 4-day lead-in pretreatment with antibiotic placebo, then matching placebo for SER-401 and nivolumab (480 mg) treatment. Placebo for antibiotic: Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout. Nivolumab: Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks. Matching Placebo for SER-401: Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. | 1 | 6 | 1 | 6 | 6 | 6 |
| EG001 | SER-401/ Nivolumab | Participants will undergo a 4-day lead-in pretreatment with antibiotic (vancomycin) to prime the gut microbiome for engraftment of the oral microbiome study intervention, then SER-401 and nivolumab treatment. Vancomycin pretreatment: Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout. Nivolumab: Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks. SER-401: Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. | 4 | 8 | 1 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary adrenal insufficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Nodule | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Anal incontinence | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Defaecation urgency | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dental discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Skin weeping | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Brain oedema | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Phantom limb syndrome | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash pustular | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Tinea versicolour | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Pallor | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Raynaud's phenomenon | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| Mastoid disorder | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Wound drainage | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ute Dugan | Parker Institute for Cancer Immunotherapy | 203-379-6757 | udugan@parkerici.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2021 | Oct 4, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| High |
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| 1 |
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| IIC |
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| IIIA |
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| IIIB |
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| IIIC |
|
| IV |
|
| Unknown |
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| IIIB |
|
| IIIC |
|
| IV |
|
| Cutaneous |
|
| Mucosal |
|
| Unknown |
|
| Grade 5 TRAE |
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| Serious TRAE |
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| TRAE leading to treatment discontinuation |
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