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Phase: II

81 protocol(s) meet the specified criteria. Please click on the protocol number to get more information about the trial.

Doctor	Protocol No.	Title
Anand, Neel	KUR-113/01	A proSpecTive, Randomized, controlled, single-blind, dose-finding, mUlti-Center, parallel group study of the safeTy and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) versus local autograft for the treatment of patients undergoing single-level transforaminal lumbar intErbody fusion (the STRUCTURE study)
Ayoub, Walid	GT-031-NASH-RX	A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis
Ayoub, Walid	VLX-301	A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
Bairey-Merz, Noel	CLBS16-P02	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CLBS16 DELIVERY BY INTRACORONARY OR RETROGRADE CORONARY SINUS ADMINISTRATION IN SUBJECTS WITH CORONARY MICROVASCULAR DYSFUNCTION AND WITHOUT OBSTRUCTIVE CORONARY ARTERY DISEASE (PHASE 2)
Ben-Shlomo, Anat	CIN-107-122	A randomized, double-blind, placebo-controlled, multicenter, parallel-group, dose-ranging study to evaluate the efficacy and safety of CIN-107 for the treatment of patients with primary aldosteronism (PA).
Burford, Matthew	APL2-ALS-206	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Burwick, Richard	IIT-BURWICK2019	Complement Regulation to Undo Systemic Harm in Preeclampsia: The CRUSH Study
Chen, Peter	J2W-MC-PYAB	PYAB: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants with Mild to Moderate COVID-19 Illness
Chiu, Vi K.	DEK-DKK1-P205	DEK-DKK1-P205: A Phase 2a, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish) (IRB#782)
Chung, Alice	IIT2015-06-CHUNG-SNBO	Safety and Efficacy of Omission of Sentinel Node Biopsy in Patients With Clinical T1-2 Estrogen-Positive Breast Cancer Over Age 65 (IRB#41396)
D'Agnolo, Alessandro	IIT2020-14-DAGNOLO-HIFU	IIT2020-14-DAGNOLO-HIFU: High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy or Radical Prostatectomy (IRB#832)
Darrah, Justin	S1918	S1918: A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed diffuse large B cell lymphoma, Grade IIIb Follicular Lymphoma, transformed lymphoma, and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements (IRB#1591)
Freedland, Stephen	IIT2018-06-FREEDLAND-AS3	IIT2018-06-FREEDLAND-AS3 (CAPS3): Carbohydrate and Prostate Study 3: Carbohydrate restricted diet intervention for men on prostate cancer active surveillance (IRB#53710)
Freedland, Stephen	IIT2018-23-FREEDLAND-POWR	IIT2018-23-Freedland-POWR: WALNUTS for POWER: Polyphenols, Omega-3 fatty acids, Weight loss, and EneRgy (IRB#55792)
Gangi, Alexandra	EA2197	EA2197: Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial (IRB#01464)
Gong, Jun	ACCRU-GI-1623	ACCRU-GI-1623: (PULSE) A Randomized, Phase II Open-Label Study of Panitumumab Rechallenge Versus Standard Therapy after Progression on Anti-EGFR Therapy in Patients with Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer (IRB#802)
Hage, Antoine	INS1009-202	A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension
Hamid, Omid	EIIT2020-HAMID-S19-00008	S19-00008: A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination with Ipilimumab and Nivolumab in Patients with Unresectable Stage III or Stage IV Melanoma (IRB #390)
Hamid, Omid	ITIL-168-101	ITIL-168-101: A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects with Advanced Melanoma (DELTA-1) (IRB#1009)
Hamid, Omid	SGNS40-002	SEA-CD40: An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies (IRB#1543)
Hamid, Omid	TAPUR	Targeted Agent and Profiling Utilization Registry (TAPUR) Study (IRB#49119)
Hendifar, Andrew	ACCRU-GI-1907	ACCRU-GI-1907 (BrafPanc): A Phase II Trial of Binimetinib in Combination with Encorafenib in Patients with Pancreatic Malignancies and a Somatic BRAF V600E Mutation (IRB#858)
Hendifar, Andrew	IIT2018-29-HENDIFAR-PNCX3	IIT2018-29-Hendifar-PNCX3: PANCREATIC-ENZYME REPLACEMENT THERAPY WITH PANCREAZE (PANCRELIPASE) DELAYED-RELEASE IN ADDITION TO STANDARD OF CARE FOR BORDERLINE RESECTABLE, LOCALLY ADVANCED, ADVANCED, AND UNRESECTABLE PANCREATIC ADENOCARCINOMA PATIENTS (PANCAX-3) WITH CACHEXIA AND EXOCRINE PANCREATIC INSUFFICIENCY (IRB#208)
Hendifar, Andrew	MK-3475-158	MK-3475-158-00: A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158) (IRB#43687)
Hendifar, Andrew	MK-7339-002	MK7339-002: A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (IRB#57241)
Hendifar, Andrew	MK6482-015	MK6482-015: A Study of MK-6482 Monotherapy in Advanced Pheochromocytoma/Paraganglioma (PPGL) and Pancreatic Neuroendocrine Tumors (pNET) (IRB#1491)
Hendifar, Andrew	NEAAR-001	NEAAR-001: Prospective Single Arm Medical Food Study to Evaluate a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food for the Dietary Management of Metastatic Pancreatic Cancer (IRB#1496)
Hu, Jethro	GCAR-7213	GCAR-7213: GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM) (IRB#52)
Jordan, Stanley	16-HMEDIDES-12	A Randomized, Open-Label, Multi-Centre, Active Control Study Investigating the Efficacy and Safety of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients
Jordan, Stanley	CLAZACOVID19	A Phase II Trial to Evaluate the Safety and Tolerability of Clazakizumab® (Anti-IL-6 monoclonal) compared to placebo for the treatment of COVID-19 infection
Jordan, Stanley	MAU868-201	A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Efficacy of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
Kamil, Elaine	GFB-887-201	A PHASE 2A MULTIPLE ASCENDING, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF GFB-887, A TRPC5 CHANNEL INHIBITOR, IN PATIENTS WITH DIABETIC NEPHROPATHY, FOCAL SEGMENTAL GLOMERULOSCLEROSIS, AND TREATMENT-RESISTANT MINIMAL CHANGE DISEASE
Kamrava, Mitchell	GTI-4711-201	GTI-4711-201 (GRECO-2): A Randomized, Phase 2 Study of Stereotactic Body Radiation Therapy (SBRT) in Combination with GC4711 in the Treatment of Unresectable or Borderline Resectable, Nonmetastatic Pancreatic Cancer (IRB#1197)
Labadzhyan, Artak	ISIS766720-CS5	An Open Label, Randomized, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of IONIS GHR-LRX, an Antisense Inhibitor of the Growth Hormone Receptor, Administered Monthly as Monotherapy in Patients with Acromegaly
Lo, Simon	NANOPAC-2016-05	NANOPAC-2016-05: Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac in Subjects with Locally Advanced Pancreatic Adenocarcinoma (IRB#49989)
Majlessipour, Fataneh	APEC1621B	APEC1621B: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of JNJ-42756493 (Erdafitinib) in patients with tumors harboring FGFR1/2/3/4 alterations (IRB#57477)
Majlessipour, Fataneh	APEC1621MASTER-APEC1621SC	APEC1621MASTER-APEC1621SC: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Master and Screening Protocol (IRB#57413)
Makkar, Rajendra	2018-19	The ENCIRCLE High-Risk Trial SAPIEN M3 System TransCatheter MItral Valve ReplaCement via TransseptaL AccEss
Mehmi, Inderjit	ALKS4230-006	A Phase 2, Open-label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]1 Therapy - ARTISTRY-6 (IRB#1206)
Mehmi, Inderjit	EA6191	EA6191: The BAMM2 (BRAF, Autophagy, MEK inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib with or without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma (IRB#1406)
Mehmi, Inderjit	EA6192	EA6192: A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop) (IRB#1205)
Mehmi, Inderjit	SGN35-033	SGN35-033: A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies after progression on prior PD-1 inhibitor treatment (IRB#1070)
Melmed, Gil	TAK-018-2001	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease Recurrence
Merchant, Akil	A051902	A051902: A randomized phase II study of CHO(E)P vs CC-486- CHO(E)P vs duvelisib-CHO(E)P in previously untreated CD30 negative peripheral T-cell lymphomas (IRB#1890)
Merin, Noah	GS-US-546-5920	GS-US-546-5920: A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients with Myeloid Malignancies (IRB#1458)
Mita, Alain	P1719-SUR-Z11	P1719-SUR-Z11: A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in combination with Low Dose Cyclophosphamide and Pembrolizumab, in Subjects with Selected Advanced and Recurrent Solid Tumours. (IRB#57155)
Natale, Ronald	D6186C00001	D6186C00001:A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy (ORCHARD) (IRB#97)
Natale, Ronald	MK-7684A-002	MK-7684A-002-00: A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy (IRB#1621)
Natale, Ronald	ML41591	ML41591: Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Alectinib, Entrectinib, or Vemurafenib plus Cobimetinib in Patients With Stages I-III Non-Small Cell Lung Cancer With ALK, ROS1, NTRK, Or BRAF V600E Molecular Alterations (IRB#715)
Noureddin, Mazen	AK-US-001-0102	A PHASE 2B/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN NON-CIRRHOTIC SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH)
Noureddin, Mazen	C2541013	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING, DOSE-FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-06865571 (DGAT2I) ALONE AND WHEN COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH BIOPSY-CONFIRMED NONALCOHOLIC STEATOHEPATITIS AND FIBROSIS STAGE 2 OR 3
Noureddin, Mazen	LJN452D12201C	A randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor (LJN452) & licogliflozin (LIK066) combination therapy, to each monotherapy, for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis (ELIVATE)
Noureddin, Mazen	VK2809-202	VK2809 A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF VK2809 ADMINISTERED FOR 52 WEEKS FOLLOWED BY A 4-WEEK OFF-DRUG PHASE IN SUBJECTS WITH BIOPSY PROVEN NON-ALCOHOLIC STEATOHEPATITIS WITH FIBROSIS
Osipov, Arsen	EIIT2020-OSIPOV-PEMDEF	EIIT2020-Osipov-PemDef/J18140: A randomized phase II study of pembrolizumab with or without defactinib, a focal adhesion kinase inhibitor following chemotherapy as a neoadjuvant and adjuvant treatment for resectable pancreatic ductal adenocarcinoma (PDAC) (IRB#1038)
Padda, Sukhmani	BA3011-002	BA3011-002: A Phase 2 Study of BA3011 Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer Who Had Prior Disease Progression on a PD- 1/L-1 Inhibitor. (IRB#STUDY00001623)
Padda, Sukhmani	S1900E	S1900E: A PHASE II STUDY OF AMG 510 IN PARTICIPANTS WITH PREVIOUSLY TREATED STAGE IV OR RECURRENT KRAS G12C MUTATED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (IRB#01520)
Patil, Chirag	BPM31510IV-11	BPM31510IV-11: A Phase 2 study of BPM31510 with Vitamin K1 in subjects with newly diagnosed glioblastoma (GB) (IRB#1332)
Rader, Florian	CIN-107-121	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CIN-107 as Compared to Placebo After12 Weeks of Treatment in Patients With Treatment-Resistant Hypertension (rHTN)
Rader, Florian	CY6021	A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CK3773274 IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY AND LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION
Rader, Florian	MYK-461-019	AN EXPLORATORY, OPEN-LABEL, PROOF-OF-CONCEPT, PHASE 2A STUDY OF MAVACAMTEN (MYK-461) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF) AND CHRONIC ELEVATION OF CARDIAC TROPONIN I AND/OR NT-PROBNP
Reckamp, Karen	ELVCAP-001-01	ELVCAP-001-01: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors (IRB#862)
Reckamp, Karen	GO42501	GO42501: A Phase II, Open-Label, Multicenter Study Evaluating The Safety And Efficacy of Neoadjuvant and Adjuvant Tiragolumab plus Atezolizumab,with or without Platinum-Based Chemotherapy, in Patients with Previously Untreated Locally Advanced Resectable Stage II, IIIA. or Select IIIB Non-Small Cell Lung Cancer (IRB#1128)
Reckamp, Karen	S1929	S1929: Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC) (IRB#1178)
Rimel, Bobbie Jo	213409	GSK 213409: An Open-Label, Multicenter, Long-Term Treatment Extension Study in Subjects Who Have Completed a Prior 213409 Glaxosmithkline/Tesaro-Sponsored Niraparib Study and are Judged by the Investigator to Benefit from Continued Treatment with Niraparib (IRB#1281)
Rimel, Bobbie Jo	EIIT2021-RIMEL-NWU20-02-01	EIIT2021-Rimel-NWUEIN: Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia (NWU20-012-01) (IRB#1419)
Rimel, Bobbie Jo	NRG-GY012	NRG-GY012: A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent, or Metastatic Endometrial Cancer (IRB#55220)
Sandler, Howard	RTOG-3506	RTOG-3506: (STEEL) A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features (IRB#220)
Spiegel, Brennan	IIT2021-05-SPIEGEL-VR	IIT2021-05-SPIEGEL-VR: Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes (IRB#1363)
Sundaram, Vinay	DUR-C928-011	A Randomized, Double-blind, Placebo-controlled, Phase 2b study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Alcoholic Hepatitis
Syal, Gaurav	PR200-102	A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis
Syal, Gaurav	PR200-103	A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn's Disease
TEST, STAFF3	TEST3	TEST3: Faux study 3 for testing
Tagliati, Michele	BN42358	A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Intravenous Prasinezumab In Participants With Early Parkinson's Disease
Tagliati, Michele	TAK-071-2002	A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls
Tapson, Victor	20-0006-ACTT	A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
Thompson, Patricia	EIIT2021-THOMPSON-STOPBC	EIIT2021-THOMPSON-STOPBC: Double-blind, randomized phase II clinical trial of sulindac for reducing breast density in postmenopausal women at risk of developing breast cancer (IRB #1462)
Wentzel, Kristopher	8951-CL-0103	A Phase 2 Study of IMAB362 as Monotherapy or in Combination with mFOLFOX6 in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma whose Tumors have High or Intermediate Claudin (CLDN) 18.2 Expression. (IRB#52384)
Yang, Ju Dong	IIT2020-01-YANG-G1001	IIT2020-01-YANG-G1001:Case-Control Study of the Glycotest HCC Panel vs AFP for the Detection of Early-Stage Hepatocellular Carcinoma (IRB#399)
Zaman, Tanzira	PLN-74809-IPF-202	A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF)
Zumsteg, Zachary	IIT2019-20-ZUMSTEG-HPVOPC	IIT2019-20-ZUMSTEG-HPVOPC: Phase II Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer (IRB#900)
Zumsteg, Zachary	RTOG-1216	RTOG-1216: Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck (IRB#1160)