Submitted by klmcguire on Thu, 02/27/2020 - 10:14

Carilion Clinic's Gynecologic Oncology research program conducts numerous progressive research trials through its affiliations with the Gynecologic Oncology Group (GOG), the National Cancer Institute (NCI) and leaders in the pharmaceutical research industry. This research is targeted to ovarian, cervical, uterine and vulvar cancers and provides specialized options for patients in all cancer stages.

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Oregovomab for Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma

A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) In Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma

PROTOCOL DESCRIPTION

The primary objective of this phase 3 study is to determine the efficacy by progression free survival (using investigator assessment of scans) of oregovomab compared to placebo when administered in combination with a standard chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery, using a strict, double-blind, placebo-controlled design. 

Inclusion Criteria:

  • Adults 18 years old or older
  • Subjects with newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO stage III or IV disease
  • Eligible histologic epithelial cell types: high-grade serous adenocarcinoma, high-grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified (NOS)
  • Completed debulking surgery (either primary debulking surgery or interval debulking surgery)

Exclusion Criteria: 

  • BRCA1 or BRCA2 germline gene mutation test result with:
    • Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment
    • Known BRCA1 and BRCA2 somatic mutations, and known positive germline
    • Somatic homologous recombination deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy
  • Subjects with mucinous adenocarcinoma and low-grade adenocarcinoma

Primary Investigator: 
David Iglesias, M.D.

Contact Information: 
Carla Crupnick, B.S.N., R.N.
Clinical Research Nurse Coordinator
Carilion Clinic GYN/Oncology
Office: 540-581-0241
Fax: 540-983-1285
crcrupnick@carilionclinic.org

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Oregovomab for Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma
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Testing the Addition of the Antibody, Atezolizumab, to Chemotherapy With Liposomal Doxorubicin and Bevacizumab in Recurrent Ovarian Cancer

PROTOCOL ID NRG GY009

PROTOCOL DESCRIPTION The purpose of this study is to compare any good and bad effects of adding atezolizumab to the usual chemotherapy (Doxil) and to the usual chemotherapy with bevacizumab. Atezolizumab is a PD-L1 inhibitor that may allow the immune system to recognize and destroy tumor cells. 

ELIGIBILITY CRITERIA

  • High-grade ovarian cancer, including high-grade serous; clear cell; endometrioid, grade 3; and others (adenocarcinoma, NOS; mixed epithelial carcinoma; undifferentiated carcinoma)
  • Recurrent, platinum-resistant ovarian cancer (defined as progression within < 6 months from completion of platinum-based therapy)
  • Measurable disease or evaluable disease
  • Age ≥18
  • The trial is open to females only

EXCLUSION CRITERIA

  • Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Patients who have had systemic anticancer therapy (e.g., chemotherapy, targeted therapy) within 3 weeks prior to entering the study
  • Patients who have had hormonal therapy (e.g., tamoxifen, aromatase inhibitor) within 1 week prior to entering the study
  • Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents
  • Patients with prior treatment with bevacizumab for platinum resistant recurrence (note: prior bevacizumab in initial therapy and/or platinum-sensitive recurrent setting is allowed)
  • Patients with prior treatment with PLD
  • Prior radiotherapy to the abdomen or pelvis

Primary Investigator: David Iglesias, M.D.

Contact Information: Carla Crupnick, B.S.N., R.N. Clinical Research Nurse Coordinator Office: 540-581-0241 crcrupnick@carilionclinic.org

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Recurrent Ovarian Cancer Study
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Dostarlimab in Combination with Chemotherapy for Recurrent or Stage III or IV Endometrial Cancer

A Phase 3, Randomized, Double-Blind, Multicenter Study of Dostarlimab (TSR 042) plus Carboplatin-paclitaxel versus Placebo Plus Carboplatin-paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer (RUBY) (GOG 3031)

PROTOCOL DESCRIPTION

This is a phase 3, randomized, double-blind, multicenter study to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in patients with recurrent or primary advanced (stage III or IV) endometrial cancer. Eligible subjects will be randomized in a 1:1 ratio to receive either dostarlimab plus carboplatin-paclitaxel or placebo plus carboplatin-paclitaxel.

Inclusion Criteria:

  • Female subject at least 18 years of age
  • Endometrial cancer with recurrent or advanced disease
  • Subject must have primary stage III or stage IV disease or first recurrent endometrial cancer
  • Subject has an ECOG performance status of 0 or 1

Exclusion Criteria:

  • Subject has received neo-adjuvant/adjuvant systemic chemotherapy for primary stage III or IV disease
  • Subject has had >1 recurrence of endometrial cancer
  • Subject has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1, or anti-programmed cell death-ligand 2 agent
  • Subject has received prior anticancer therapy within 21 days

Primary Investigator: 
David Iglesias, M.D.

Contact Information:
Carla Crupnick, B.S.N., R.N.
Clinical Research Nurse III
Carilion Clinic GYN/Oncology
Office: 540-581-0241
crcrupnick@carilionclinic.org  

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Dostarlimab in Combination with Chemotherapy for Recurrent or Stage III or IV Endometrial Cancer
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Tumor Treating Fields Concomitant with Weekly Paclitaxel for the Treatment of Platinum-Resistant Ovarian Cancer

ENGOT-ov50 / INNOVATE-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 200kHz) concomitant with weekly paclitaxel for the treatment of platinum-resistant ovarian cancer (PROC)

PROTOCOL DESCRIPTION

Pivotal, randomized (1:1), open-label, two-arm, multicenter study of the NovoTTF-100L(O) system. The NovoTTF-100L(O) system is an investigational medical device delivering 200 kHz TTFields to the abdomen and pelvis for the treatment of patients age 18 years or older with platinum-resistant ovarian, primary peritoneal or fallopian tube carcinomas, in combination with weekly paclitaxel. It is intended to be used for at least 18 hours per day on a monthly average and exclusively by patients in a clinical trial.

Inclusion Criteria:

  • 18 years of age and older
  • Epithelial histology of ovarian/primary peritoneal or fallopian tube carcinoma at the time of diagnosis
  • Maximum two prior lines of systemic therapy following diagnosis of platinum-resistance
  • Maximum total of five prior lines of systemic therapy

Exclusion Criteria: 

  • Prior disease progression on a weekly paclitaxel for recurrent disease
  • Brain metastasis or leptomeningeal spread of the tumor
  • Implantable electronic medical devices in the torso
  • Known allergies to medical adhesives or hydrogel
  • Prior malignancies treated primarily or for recurrence within 2 years prior to inclusion in this study, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma of the skin or cervix of the uterus

Primary Investigator: 
David Iglesias, M.D.

Contact Information: 
Carla Crupnick, B.S.N., R.N.
Clinical Research Nurse Coordinator
Carilion Clinic GYN/Oncology
Office: 540-581-0241
Fax: 540-983-1285
crcrupnick@carilionclinic.org

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Tumor Treating Fields for PROC
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Genmab - ENGOT-cx8 - GOG-3024

A phase 2 open-label trial of tisotumab vedotin (HuMa-TF-ADC) alone of in combination with other agents in subjects with recurrent or Stage IVB cervical cancer

PROTOCOL DESCRIPTION

This is an open label, multicenter trial of tisotumab vedotin as monotherapy or tisotumab vedotin in combination in subjects with recurrent or stage IVB squamous, adenosquamous or adenocarcinoma of the cervix who are not amenable to curative treatment with surgery and/or radiation therapy and who have not received prior systemic therapy for their recurrent or stage IVB disease.

Inclusion Criteria:

  • Female and not pregnant, breastfeeding or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration (All Arms)
  • Must have squamous, adenosquamous or adenocarcinoma of the cervix (Arms D and E Only)
  • Must have squamous, adenosquamous or adenocarcinoma of the cervix and progressed on or after at least one but no more than two prior systemic therapies for recurrent or stage IVB cervical cancer (Arm F only)
  • Must have baseline measurable disease per RECIST v1.1 (All Arms)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms)

Exclusion Criteria:

  • Subjects are excluded if they are candidates for curative therapy by means of pelvic exenteration
  • Clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage
  • Clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition

Primary Investigator: 
David Iglesias, M.D.

Contact Information:
Carla Crupnick, B.S.N., R.N.
Clinical Research Nurse III
Carilion Clinic GYN/Oncology
Office: 540-581-0241
crcrupnick@carilionclinic.org  

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Recurrent or Stage IVB Cervical Cancer study
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Cellular and Molecular Factors Affecting Ovarian Cancer Metastasis

PROTOCOL DESCRIPTION

The purpose of this research is to determine whether obesity changes the composition or makeup of fat cells in different parts of the body, resulting in an increase in cancer growth or spread. The tissue samples collected for this study will be obtained at the time of the patient’s standard-of-care procedure (paracentesis or surgery). Of note, once the patient has completed the initial consent and tissue collection, she will not be contacted again regarding this research study.

Inclusion Criteria:

  1. Diagnosis or suspicion of ovarian, fallopian tube or primary peritoneal carcinoma or a benign gynecologic condition with presence of ascites that can be adequately drained during routine course of treatment
  2. Patients who are or will be scheduled for surgery, biopsy or procedure as part of their routine care for an established or suspected ovarian, fallopian tube or primary peritoneal malignancy or other gynecologic abnormality (benign or pre-malignant conditions) with presence of ascites
  3. Any patient undergoing a therapeutic or diagnostic paracentesis
  4. Age greater than 18 years

Exclusion Criteria: 

  1. Absence of ascites or ascites that is not amenable to drainage
  2. Diagnosed malignancy other than ovarian, fallopian tube or peritoneal cancer
  3. Incapable of providing consent for surgery and/or specimen collection

Primary Investigator: 
David Iglesias, M.D.

Contact Information: 
Danielle Mitchell
Clinical Research Coordinator II
Carilion Clinic GYN/Oncology
Mobile: 540-521-1355
ddmitchell@carilionclinic.org

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Ovarian Cancer Metastasis
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Prospective Randomized Trial of Streamlined Genetic Education and Testing for Ovarian, Fallopian and Peritoneal Cancer Patients

PROTOCOL DESCRIPTION

This study examines a new model of patient education prior to genetic testing. Currently, it is recommended that all patients with epithelial ovarian, fallopian tube, or peritoneal cancer receive genetic testing. The traditional model for this kind of testing starts with education provided during a formal meeting with a genetic counselor. Patients that participate in this study will be placed into either a group that receives education via the traditional model, or a group that receives a video-assisted form of patient education. By comparting these two groups, we hope to see if the new model is a safe and effective way to provide education prior to genetic testing.

Inclusion Criteria:

  1. Either a) pathologically confirmed diagnosis of high-grade epithelial ovarian, fallopian, or peritoneal cancer via biopsy or surgical pathology or b) cytologic diagnosis consistent with epithelial ovarian cancer
  2. Must present to Carilion Clinic for first outpatient visit following pathologic or cytologic diagnosis; if logistic constraints prevent the patient from being enrolled at her initial visit, she will be eligible for enrollment up to initiation of her fifth cycle of chemotherapy
  3. Age greater than 18 years

Exclusion Criteria: 

  1. Known family or personal history of an inherited cancer susceptibility mutation
  2. Diagnosis of ovarian, fallopian tube, or peritoneal cancer not consistent with high grade epithelial histology
  3. Previously received genetic counseling or testing for an inherited cancer susceptibility mutation
  4. Unable to read or speak English as study design includes video assisted educational materials in English
  5. Blind or deaf as study design includes video assisted educational materials in English

Primary Investigator: 
David Iglesias, M.D.

Contact Information: 
Danielle Mitchell
Clinical Research Coordinator II
Carilion Clinic GYN/Oncology
Mobile: 540-521-1355
ddmitchell@carilionclinic.org

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Streamlined Genetric Education & Testing
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NRG-GY020: A Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

PROTOCOL DESCRIPTION

This study has two randomized study groups:

  • Group 1: This group will receive radiation therapy with vaginal brachytherapy.
  • Group 2: This group will receive radiation therapy with vaginal brachytherapy in combination with a study drug called pembrolizumab.

Inclusion Criteria:

  • Stage I endometrioid endometrial cancer with a combination of age and risk factors

OR Stage II endometrioid endometrial cancer:

  • CT or MRI abdomen or pelvis and either chest X-ray or CT chest demonstrating no evidence of disease outside of the uterus.
  • Patients must have deficient mismatch repair as demonstrated by lack of expression of at least one mismatch repair protein by IHC and/or evidence of MSI high.
  • Patients must have undergone surgical staging with at least hysterectomy, removal of cervix, bilateral (if both are present) salpingo-oophorectomy and either sentinel lymph node assessment or complete pelvic +/- aortic lymphadenectomy.
  • Patients must have received no prior therapy for endometrial cancer, including hormonal therapy, chemotherapy, targeted therapy, immunotherapy or radiation therapy.

Exclusion Criteria:

  • Patients who are currently participating and receiving cancer-directed study therapy for endometrial cancer or have participated in a study of an investigational agent and received cancer-directed study therapy for endometrial cancer within 4 weeks prior to registration.
  • Patients who have received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents.
  • Patients who have a history of a severe hypersensitivity reaction to monoclonal antibody or pembrolizumab (MK-3475) and/or its excipients.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune-suppressive treatment, including systemic corticosteroids.
  • Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.

Primary Investigator(s)
David Iglesias, M.D.

Contact Information
Carla Crupnick, B.S.N., R.N.
Clinical Research Nurse III
Carilion Clinic GYN/Oncology
Office: 540-581-0241
crcrupnick@carilionclinic.org  

Section Title
Radiation +/- Pembrolizumab for Newly Diagnosed Early Stage Endometrial Cancer
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