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BREAST: ADJUVANT: ER+:HER2-:PREMENOPAUSAL: ONCOTYPE <25: OFSET

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast cancer, ER positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

chemotherapy, ovarian suppression, and endocrine therapy

Drug Class

chemotherapy, ovarian suppression, and endocrine therapy

PI

Greg Vidal, MD, PhD

Sponsor

NRG Oncology

Path

adenocarcinoma

Key Eligibility Criteria Details
  • Premenopausal
    • Age 40 years or under with spontaneous menses within 12 months
    • Age 50-60 years with spontaneous menses within 12 months plus FSH and estrodiol measurements within premenopausal range
    • Amenorrhea due to IUD or uterine ablation or hysterectomy must have FSH and estrodiol ranges in premenopausal range
  • ECOG PS 0-2
  • Multicentric or multifocal breast cancer is allowed
  • Must have had definitive breast surgery (+radiation if indicated)
  • Primary tumor must be T1-3
  • Nodes must be N0 or N1
  • Oncotype score must be,
    • if node negative: 21-25 or high clinical risk (with oncotype 16-20)
    • If 1-3 nodes, must be <26
  • Must be ER/PR positive
  • Must be HER2 negative
  • No metastatic disease
OVARIAN: RECURRENT: PLATINUM SENSITIVE: 3rd LINE: FOLATE-RECEPTOR+: GLORIOSA

Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab (GLORIOSA)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian, Fallopian Tube, Primary Peritoneal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

3rd Line

Investigational Agent

Mirvetuximab soravtansine plus bevacizumab

Drug Class

Ab drug conjugate against folate receptor alpha + VEG-F inhibitor

PI

Todd Tillmanns, MD

Sponsor

Immunogen, Inc.

Path

High grade serous ovarian/primary peritoneal/fallopean tube cancer

Key Eligibility Criteria Details
  • ECOG PS 0-1
  • Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • If patients are BRCA positive, must have received treatment with PARP inhibitors
  • Must be folate receptor alpha positive as defined by FRa positivity of >75% of tumor membrane staining at 2+ intensity or higher.
  • Disease must have relapsed after 1 line of platinum-based therapy and must be platinum-sensitive defined as progression greater than 6 months from last dose of primary platinum therapy
  • Must be appropriate for, currently be on, or have completed platinum-based triplet therapy in the second line. Must have received no less than 4 and no greater than 8 cycles in the second line
  • Must have receirved, be currently be receiving, or be planned to receive paclitaxel, gemcitabine, pegylated lipsomal doxorubicin as the partner drug to platinum based therapy
  • After completion of platinum based triple therapy and before randomization, patient must have achieved a CR, pR, or SD
  • Before randomization must have either a) measurable disease, b) persistently elevated CA-125 or c) no evidence of disease and normalization of CA-125
  • No endometrioid, clear cell, mucinous, or sarcomatous histology
  • No more than 1 line of prior chemotherapy before planned triplet therapy
  • No PD while on triple therapy
  • No cirrhotic liver disease
  • No severe cardiac disease
  • No history of bowel obstruction, abdominal fistula, or GI perforation
  • No folate deficiency
  • No other malignancy within 3 years
Advanced Solid Tumors: Niraparib and Dostarlimab in HRD Solid Tumors

A Phase II Trial of Niraparib and Dostarlimab Combination Therapy in Patients
with Somatic Homologous Recombination Deficient Advanced or Metastatic
Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

solid tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Niraparib and Dostarlimab

Drug Class

PARP inhibitor + IgG4 humanized monoclonal antibody resulting in PDL1/2 inhibition.

PI

Gregory Vidal, MD

Sponsor

West Cancer Center

Path

somatic HRD deficiency

Key Eligibility Criteria Details
  1. Metastatic, recurrent, or unresectable solid tumor with a pathogenic, or presumed pathogenic, somatic mutation of one of the following homologous recombination deficiency (HRD) gene mutations:  BRCA1, BRCA2, ATM, RAD51B, RAD51C, RAD54L, RAD51D, FANC/BRIP1, FANCI, FANCL, FANCN(PALB2), BARD1, CHEK1, CHEK2, CDK12, or PPP2R2A.

  2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  3. Participant must be ≥ 18 years of age
  4. Participant must have adequate organ function, defined as follows:

    • Absolute neutrophil count ≥ 1,500/µL
    • Platelets ≥ 100,000/µL
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min using the Cockcroft-Gault equation
    • Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
    • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
    • International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  5. Female participant has a negative serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to use a highly effective method of contraception from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):
    • ≥45 years of age and has not had menses for >1 year
    • Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
    • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use an adequate barrier method throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 5.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.

h. Male participant agrees to use a highly effective method of contraception (see Section 5.4 for a list of acceptable birth control methods) starting with the first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.

j. If an appropriate archival tumor tissue sample is not available, patient is willing to undergo a pre-treatment tumor biopsy.

Exclusion Criteria:

  1. Patients with the following malignancies will be excluded:

    • Prostate cancer
    • Ovarian, breast, and pancreatic patients with known germline BRCA1 or BRCA2 mutation
    • Platinum sensitive ovarian cancer (defined as recurrence > 6 months from last platinum agent), unless platinum intolerant.
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