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CERVICAL: SURGICAL: ROBOTIC VERSUS OPEN HYSTERECTOMY: GOG 3043

A Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Cervical cancer, cervix

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Robotic hysterecomty

Drug Class

N/A

PI

Michael Ulm, MD

Sponsor

GOG (Gynecologic Oncology Group)

Path

Adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma (including glassy cell)

Key Eligibility Criteria Details

Inclusion Criteria:

  1. Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
  2. Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patients with tumor size less than or equal to 4 cm confirmed on MRI prior to randomization are eligible.
  3. Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.
  4. Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard.
  5. Patient must be age 18 years or older.
  6. Patient must have ECOG performance status 0-1.
  7. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.
  8. Patient must have signed an approved informed consent and authorization permitting the release of personal health information.

Exclusion Criteria:

  1. Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation)
  2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
  3. Patient with inability to receive an MRI.
  4. Patients with a tumor size greater than 4cm or on MRI confirmed prior to randomization are excluded. Patients with definite evidence of vaginal/parametrial involvement on MRI are excluded; if MRI findings are not definitive, then clinical examination must also not reveal parametrial or vaginal extension).
  5. Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
  6. Patients with a history of prior pelvic or abdominal radiotherapy.
  7. Patients with a prior malignancy < 5 years from enrollment with the exception of non-melanoma skin cancer.
  8. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
  9. Patient compliance and geographic proximity that do not allow adequate follow-up.
  10. Patients with poorly controlled HIV with CD4 counts <500.
ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

PI

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
  • Must have tumor specimen available
  • Measurable disease
  • ECOG PS 0-1
  • Life expectancy at least 12 weeks
  • Phase 1a- must have exhausted all standard therapies for their disease
  • Phase 1b- must have disease that has progressed after at least one available standard therapy
  • Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
  • No active HBV/HCV or chronic or acute EBV
  • No history of autoimmune disease
  • No symptomatic or actively progressing CNS mets
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