{"preliminary_commentary":{"by_channel":{"x_thread":36,"podcast":12,"youtube":7,"x_video":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03170960\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"COSMIC-021","nct_id":"NCT03170960","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=cosmic-021-nct03170960. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Subjects will accrue in cohorts of 3-6 subjects for evaluation of cabozantinib tablet dose of either 20 mg, 40 mg, and 60 mg orally qd in combination with standard dosing regimen of atezolizumab (1200 mg infusion q3w). A standard \"3 plus 3\" design will be utilized to determine a recommended combination dosing regimen for the Expansion Stage.","label":"Dose Escalation","type":"EXPERIMENTAL"},{"description":"RCC subjects with clear cell histology who have not received prior systemic anticancer therapy.","label":"Expansion Cohort 1","type":"EXPERIMENTAL"},{"description":"UC subjects (including bladder, renal pelvis, ureter, urethra) who have progressed on or after platinum-containing chemotherapy.","label":"Expansion Cohort 2","type":"EXPERIMENTAL"},{"description":"UC subjects (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.","label":"Expansion Cohort 3","type":"EXPERIMENTAL"},{"description":"UC subjects (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.","label":"Expansion Cohort 4","type":"EXPERIMENTAL"},{"description":"UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior immune check-point inhibitor (ICI) (anti-PD1 or anti-PD-L1) therapy.","label":"Expansion Cohort 5","type":"EXPERIMENTAL"},{"description":"CRPC subjects who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease.","label":"Expansion Cohort 6","type":"EXPERIMENTAL"},{"description":"Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (ICI) (anti-PD-1 or anti-PD-L1) therapy.","label":"Expansion Cohort 7","type":"EXPERIMENTAL"},{"description":"Stage IV non-squamous NSCLC subjects with positive PD-L1 expression and without prior systemic anticancer therapy.","label":"Expansion Cohort 8","type":"EXPERIMENTAL"},{"description":"Stage IV nonsquamous NSCLC subjects with sensitizing EGFR mutation who have radiographically progressed during or following prior treatment with an EGFR-targeting TKI. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.","label":"Expansion Cohort 9","type":"EXPERIMENTAL"},{"description":"RCC subjects with non-clear cell histology who have had up to one prior VEGFR-targeting TKI therapy.","label":"Expansion Cohort 10","type":"EXPERIMENTAL"},{"description":"TNBC subjects who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.","label":"Expansion Cohort 11","type":"EXPERIMENTAL"},{"description":"OC subjects (including primary peritoneal cancer and fallopian tube cancer) who have platinum-resistant or refractory disease who have had up to two lines of prior systemic anticancer therapy.","label":"Expansion Cohort 12","type":"EXPERIMENTAL"},{"description":"EC subjects (serous or endometrioid histology) who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy.","label":"Expansion Cohort 13","type":"EXPERIMENTAL"},{"description":"HCC subjects (Child-Pugh score A) who have not received prior systemic anticancer therapy.","label":"Expansion Cohort 14","type":"EXPERIMENTAL"},{"description":"GC/GEJC/LEC subjects who have radiographically progressed during or following platinum-containing or fluoropyrimidine-containing chemotherapy.","label":"Expansion Cohort 15","type":"EXPERIMENTAL"},{"description":"CRC subjects who have radiographically progressed during or following systemic chemotherapy that contained fluoropyrimidine in combination with oxaliplatin or irinotecan.","label":"Expansion Cohort 16","type":"EXPERIMENTAL"},{"description":"H\\&N cancer subjects who have radiographically progressed during or following prior platinum-containing chemotherapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.","label":"Expansion Cohort 17","type":"EXPERIMENTAL"},{"description":"DTC subjects (follicular, papillary, and poorly differentiated histologies) who are radioactive iodine (RAI) refractory or deemed ineligible for treatment with RAI.","label":"Expansion Cohort 18","type":"EXPERIMENTAL"},{"description":"UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.","label":"Expansion Cohort 19 (SAC)","type":"EXPERIMENTAL"},{"description":"Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.","label":"Expansion Cohort 20 (SAC)","type":"EXPERIMENTAL"},{"description":"Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.","label":"Expansion Cohort 21 (SAC)","type":"EXPERIMENTAL"},{"description":"Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.","label":"Expansion Cohort 22 (SAA)","type":"EXPERIMENTAL"},{"description":"Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC","label":"Expansion Cohort 23","type":"EXPERIMENTAL"},{"description":"Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with at least one NHT and have received docetaxel for mCRPC","label":"Expansion Cohort 24","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-09-30","type":"ESTIMATED"},"conditions":["Urothelial Carcinoma","Renal Cell Carcinoma","Non-Small Cell Lung Cancer","Castration-resistant Prostate Cancer","Triple Negative Breast Cancer","Ovarian Cancer","Endometrial Cancer","Hepatocellular Carcinoma","Gastric Cancer","Gastroesophageal Junction Adenocarcinoma","Colorectal Cancer","Head and Neck Cancer","Differentiated Thyroid Cancer","Lower Esophageal Cancer"],"enrollment":{"count":914,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"cabozantinib","otherNames":["Cabometyx","XL184"],"type":"DRUG"},{"name":"atezolizumab","otherNames":["Tecentriq"],"type":"DRUG"},{"name":"cabozantinib","otherNames":["Cabometyx","XL184"],"type":"DRUG"},{"name":"cabozantinib","otherNames":["Cabometyx","XL184"],"type":"DRUG"}],"last_update":"2026-10-01","lead_sponsor":"Exelixis","official_title":"A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2023-02-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Dose Escalation: MTD/Recommended Dose","timeFrame":"Up to Day 21"},{"measure":"Dose Expansion: ORR","timeFrame":"Up to a maximum of 59 months"}],"references":[{"citation":"Pal SK, Loriot Y, Necchi A, Singh P, Castellano D, Pagliaro L, Suarez C, McGregor BA, Vaishampayan UN, Hauke RJ, Powles T, Van Herpen CML, Courtney KD, Dreicer R, Sudhagoni R, Schwickart M, Andrianova S, Agarwal N. COSMIC-021 Phase Ib Study of Cabozantinib Plus Atezolizumab: Results from the Locally Advanced or Metastatic Urothelial Carcinoma Cohorts. J Clin Oncol. 2025 May 10;43(14):1650-1662. doi: 10.1200/JCO-24-01675. Epub 2025 Feb 18.","pmid":"39965176","type":"DERIVED"},{"citation":"Li D, Loriot Y, Burgoyne AM, Cleary JM, Santoro A, Lin D, Aix SP, Garrido-Laguna I, Sudhagoni R, Guo X, Andrianova S, Paulson S. Cabozantinib plus atezolizumab in previously untreated advanced hepatocellular carcinoma and previously treated gastric cancer and gastroesophageal junction adenocarcinoma: results from two expansion cohorts of a multicentre, open-label, phase 1b trial (COSMIC-021). EClinicalMedicine. 2023 Dec 21;67:102376. doi: 10.1016/j.eclinm.2023.102376. eCollection 2024 Jan.","pmid":"38204489","type":"DERIVED"},{"citation":"Agarwal N, McGregor B, Maughan BL, Dorff TB, Kelly W, Fang B, McKay RR, Singh P, Pagliaro L, Dreicer R, Srinivas S, Loriot Y, Vaishampayan U, Goel S, Curran D, Panneerselvam A, Schwickart M, Choueiri TK, Pal S. Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: results from an expansion cohort of a multicentre, open-label, phase 1b trial (COSMIC-021). Lancet Oncol. 2022 Jul;23(7):899-909. doi: 10.1016/S1470-2045(22)00278-9. Epub 2022 Jun 9.","pmid":"35690072","type":"DERIVED"},{"citation":"Pal SK, McGregor B, Suarez C, Tsao CK, Kelly W, Vaishampayan U, Pagliaro L, Maughan BL, Loriot Y, Castellano D, Srinivas S, McKay RR, Dreicer R, Hutson T, Dubey S, Werneke S, Panneerselvam A, Curran D, Scheffold C, Choueiri TK, Agarwal N. Cabozantinib in Combination With Atezolizumab for Advanced Renal Cell Carcinoma: Results From the COSMIC-021 Study. J Clin Oncol. 2021 Nov 20;39(33):3725-3736. doi: 10.1200/JCO.21.00939. Epub 2021 Sep 7.","pmid":"34491815","type":"DERIVED"}],"start_date":{"date":"2017-09-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors","url":"https://clinicaltrials.gov/study/NCT03170960"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/cosmic-021-nct03170960"}