You may or may not be aware that the practice of medicine is research based. This means scientists and researchers start to discover and study treatments in a laboratory years before these methods become standard treatment. This is the heart of clinical research trials. New drugs and surgical techniques are studied extensively in large groups of patients comparing old methods with new ideas focusing on improved outcomes while minimizing side effects.
We have a robust Clinical Research Trial Program. This means we are able to enter our patients on national and international clinical research trials giving them access to the latest treatments available at our local office.
Dr. Sharma has been a member of the Gynecologic Oncology Group now known at NRG since 1988.
Being an active member requires vigorous scrutiny of his education and training (credentials) and allows him access to Clinical Research Trials offering the newest treatments to patients with a gynecologic cancer. What this means to you as a patient is that new drugs and procedures are offered in our office instead of you having to leave the comfort of your treatment team to travel distances to have access to the latest treatments. These research trials are closely monitored by the Investigational Review Board of Amita Health System to ensure protection of human subjects.
Clinical Research Trials are identified as Phase I, II, III, and IV. We participate primarily in Phase II and Phase III studies. Phase II studies focus on administering new drugs that may be approved in other diseases to patients with gynecologic cancers to see if the drugs are effective in managing the disease. Phase III studies are large randomized studies comparing new treatments with the standard treatments to see which treatment has better results while maintaining manageable side effects.
The following are currently active Clinical Research Trials that are being conducted at our office:
Primary Therapy Protocol – Ovarian Cancer
GOG Partners 3036 (MK-7339) - A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line treatment of BRCA non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43). Closed to New Accrual - June 18, 2021
GOG Partners 3025 (D081RC00001) – A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination with Chemotherapy (Carboplatin and Paclitaxel) and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer (DUO-O). Closed to New Accrual- February 28,2020
Maintenance Therapy Protocol – Ovarian Cancer
GOG Partners 3020 (CO-338-087) – ATHENA Study, A Randomized, Double-Blind, Placebo-Controlled Phase III Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following a Response to Front-Line Platinum-Based Chemotherapy. Closed to New Accural
Recurrent Protocols – Ovarian Cancer
GOG Partners 3045 (IMGN853-0416) - (MIRASOL) A Randomized. Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression. Closed to New Accrual - June 22, 2022
SORAYA Study (IMGN853-0417) - A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression. Closed to New Accrual
GOG Partners 3059 (AXLerate-OC) - A Phase 3, Randomized, Double-Blind, Placebo/Paclitaxel-Controlled Study of Batiraxcept (AVB-S6-500) in Combination with Paclitaxel in Patients with Platinum-Resistant Recurrent Ovarian Cancer. Closed to New Accrual - January 9, 2023
NRG-GY023 (NCT #04739800) - A Randomized Phase II Trial of Triplet Therapy (A PD-L1 Inhibitor Durvalumab in Combination with Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab and Cediranib or Standard of Care Chemotherapy in Women with Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab. Temporarily Closed to Accrual - February 2, 2023
GOG Partners 3073 - (ROSELLA) A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer. Closed to New Accrual - March 11, 2024
GOG Partners 3081 - (PRESERVE) Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients with Platinum Resistant Ovarian Cancer.
Rare Tumor/Cell Type – Ovarian Cancer
GOG 0264 – A Randomized Phase II Trial of Paclitaxel and Carboplatin Versus Bleomycin, Etoposide and Cisplatin for Newly Diagnosed, Advanced Stage and Recurrent Chemonaive Stage Sex Cord Stromal Tumors of the Ovary. Closed to New Accrual
NRG-GY014 (NCT #03348631)– A Phase II Study of Tazemetostat in Recurrent or Persistent Endometroid or Clear Cell Carcinoma of the Ovary and Recurrent or Persistent Endometroid Endometrial Adenocarcinoma. Temporarily Closed to Accrual
NRG-GY019 – A Randomized Phase III,Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum.
InterVenn Ovarian CAncer Liquid Biopsy Observational Study:
VOCAL Study - An observational study to evaluate the clinical performance of the Venn Ovarian Cancer Liquid Biopsy by collecting and analyzing a blood sample in women diagnosed with a pelvic mass who are having surgery to remove the mass (or not having surgery to remove the mass). InterVenn Biosciences is the study sponsor. Closed to New Accrual
Recurrent Protocols – Endometrial Cancer
GOG Partners 3031(4010-03-001 RUBY) – A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab plus Carboplatin-Paclitaxel Versus Placebo plus Carboplatin-Paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer. Part 2 added Niraparib/Placebo in the maintenance setting and was activated in March, 2021. Closed to New Accrual
GOG Partners 3055 (KCP-330-024) - (SIENDO) - A Randomized, Double-Blind, Phase 3 Trial of Maintenance with Selinexor/Placebo After Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer. Closed to New Accrual
NRG-GY012 (NCT #03660826) – A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab, Cediranib/Durvalumab, Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer. A Multi-Arm Trial for Women with Recurrent or Persistent Endometrial Cancer. Closed to New Accrual
NRG-GY026 (NCT #05256225) - A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab Trastuzumab and Phaluronidase-zzfx (Phesgo) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma.
GOG Partners 3089 - A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects with TP53wt Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy.
Protocols - Surgical
NRG-CC008 (NCT #04251052) - (SOROCk) A Non-Randomized Prospecitive Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers.
To learn more about these clinical trials, please use the following links:
http://www.ClinicalTrials.gov
http://www.nrgoncology.org