Clinical Trials Actively Recruiting

Objective:

Primary Objective:

• To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germ-line mutations.

Secondary Objectives:

• To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACTES sub-scale compared to women in the BSO arm.
• To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients.
• To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice.
• To assess adverse events, graded using CTCAE v5.0.

Objective:

Primary Objectives:

• To evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer

Secondary Objectives:

• To evaluate the safety and tolerability of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer
• To further evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer
• To characterize the surrogates of treatment effect

Objective:

Primary Objective:

• To evaluate the antitumor activity of nemvaleukin alfa (‘nemvaleukin’, ALKS 4230)in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancer

Secondary Objectives:

• To evaluate the antitumor activity of nemvaleukin in combination with pembrolizumab as compared with chemotherapy
• To evaluate the safety of nemvaleukin in combination with pembrolizumab as compared with chemotherapy

Objective:

Primary Objective:

• To compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib vs Investigator’s Choice of Treatment (ICT) in patients with recurrent LGSOC

Secondary Objectives:

• To compare the combination of avutometinib plus defactinib vs ICT in patients with recurrent LGSOC with regard to additional efficacy parameters
• To characterize the safety and tolerability of combination avutometinib plus defactinib vs ICT in patients with recurrent LGSOC
• To determine the exposure of avutometinib and defactinib in patients with recurrent LGSOC treated with combination of avutometinib plus defactinib
• To assess the health-related quality of life and disease related symptoms in patients with recurrent LGSOC treated with combination avutometinib plus defactinib vs ICT

Objective:

Primary Objectives:

• To evaluate the efficacy of selinexor compared to placebo as maintenance therapy

Key Secondary Objectives:

• To compare overall OS in selinexor and placebo arms

Secondary Objectives:

• To evaluate the safety and tolerability of selinexor
• To compare selinexor and placebo for time to first subsequent therapy
• To compare selinexor and placebo for time to second subsequent therapy
• To compare selinexor and placebo for time until second progression
• To assess the efficacy of selinexor compared to placebo, as assessed by a blinded independent central review (BICR)
• To evaluate health-related quality of life (HRQoL) outcomes

Objective:

Primary Objective:

• To compare the rates of lower extremity limb dysfunction (defined as a ≥4-point increase in GCLQ symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy:
  
  • Arm 1: Sentinel lymph node mapping followed by side-specific lymphadenectomy on sides without a SLN identified according to an NCCN Guidelines approved algorithm.
  • Arm 2: Sentinel lymph node mapping according to an NCCN Guidelines approved algorithm followed by bilateral pelvic +/- para-aortic lymphadenectomy.

Secondary Objectives:

• To compare changes in lower extremity limb circumference in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy. A subset of study sites will also assess limb changes over time using lower extremity bioimpedance devices.
• To validate the test characteristics of a SLN mapping algorithm including SLN detection rates, rate of perioperative complications, rate of identifying lymphatic metastases, and detection of micrometastases using pathologic ultra-staging.

Objective:

Primary Objective:

• The primary objective is to determine Progression-free Survival (PFS) by RECIST 1.1.

Key Secondary Objectives:

• To determine Objective Response Rate (ORR) and Duration of Response (DOR) by RECIST 1.1, PFS by RECIST 1.1 (in modified population), PFS by iRECIST, Overall Survival (OS), and safety.

Key Other Objectives:

• To determine ORR by the Gynecological Cancer Intergroup (GCIG) CA-125 criteria, and Clinical Benefit Rate [CBR = (CR + PR + SD ≥ 15 weeks)/total # of patients evaluated by RECIST 1.1 or iRECIST]. Additional analyses of efficacy endpoints in modified population are included.

Objective:
Primary Objective:

• To examine if letrozole monotherapy/maintenance is non-inferior to IV paclitaxel/carboplatin and maintenance letrozole with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction.

Secondary Objectives:

• To compare the nature, frequency and maximum degree of toxicity as assessed by CTCAE v5.0 for each treatment arm.
• To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm.
• To compare overall survival for each treatment arm.
• To compare the CT\L and L\L arms with respect to patients adherence to letrozole therapy as measured by pill counts.

Objective:

Primary Objectives:

Phase 2 Simon 2-Stage Study (Arm 1 Monotherapy)

• Assess the anti-tumor activity of
  ACR-368 monotherapy in each cohort
  (ovarian, endometrial, urothelial) of
  OncoSignature Positive subjects.

Phase 1b (Arm 2 Combination Therapy)

• Assess the safety and tolerability of
  ACR-368 in combination with LDG.
• Determine the RP2D of LDG

Phase 2 Exploratory Study (Arm 2 Combination Therapy)

• Assess the anti-tumor activity of
  ACR-368 in combination with LDG in
  each cohort (ovarian, endometrial,
  urothelial) of OncoSignature Negative
  subjects.

Secondary Objectives:

Phase 2 Simon 2-Stage Study (Arm 1 Monotherapy)

• Confirmation of the OncoSignature
  thresholds for enrichment of ACR-368
  monotherapy responders.
• Assess safety and tolerability of
  ACR-368 monotherapy.
• Assess efficacy, disease control,
  survival, and landmarks of survival.
• Assess RDI every 2 months.
• Assess the PK of ACR-368 in subjects
  with ovarian carcinoma
• Assess quality of life.

Phase 1b Study (Arm 2 Combination Therapy)

• Assess the anti-tumor activity of
  ACR-368 in combination with LDG.
• Assess efficacy, disease control,
  survival, and landmarks of survival.
• Assess RDI every 2 months.
• Assess the PK of ACR-368 in
  combination with LDG.

Phase 2 Exploratory Study (Arm 2 Combination Therapy)

• Assess safety and tolerability of
  ACR-368 in combination with the
  RP2D of LDG.
• Assess efficacy, disease control,
  survival, and landmarks of survival
• Assess RDI every 2 months.

Objective:

Primary Objectives:

• To investigate the safety of monotherapy and T- Plex combination TCR-Ts
• To determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

Secondary Objectives:

• To investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts
• To investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts