Phase 2
Completed N=45
Guadecitabine and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Recurrent Fallopian Tube Carcinoma · Ovarian Cancer · Recurrent Primary Peritoneal Carcinoma
Source: ClinicalTrials.gov NCT02901899 ↗
Enrolled (actual)
45
Serious AEs
41.9%
Results posted
May 2021
Primary outcomePrimary: Objective Response Rate (ORR) Using RECIST 1.1 — 3 patients
Summary
The purpose of this study is to look at how patients respond to treatment with guadecitabine and pembrolizumab. The researchers will also be looking at the amount of time it takes for cancer to get worse when participants take the study drugs. All participants will be treated with guadecitabine and pembrolizumab. Guadecitabine interferes with the cancer cells' DNA and can increase the production of certain proteins, making cancer cells more recognizable by the immune system. Pembrolizumab helps your immune system to kill cancer cells. Thus the combination of guadecitabine and pembrolizumab may increase the ability of the immune system to eliminate cancer cells. Researchers want to find out whether the combination of guadecitabine and pembrolizumab is effective in treating ovarian cancer that has not responded to traditional chemotherapy. Participants will keep receiving treatment until their cancer gets worse, they have side effects, or they decide they don't want to receive the treatment anymore. After stopping treatment, the study doctor will watch participants for side effects and follow their condition every 6-12 weeks. The study aims to keep track of participants' medical conditions for the rest of their lives. This helps us look at the long-term effects of the study drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Using RECIST 1.1 |
3 | — |
| SECONDARY Objective Response Rate (ORR) Using Immune Related Response Criteria (irRC) |
— | — |
| SECONDARY Progression Free Survival (PFS) |
1.74 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
9 | — |
| SECONDARY Incidence of Adverse Events |
41; 40; 23; 3; 33; 32 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have a histological or cytological evidence/confirmation of recurrent epithelial ovarian cancer, primary peritoneal carcinomatosis, or fallopian tube cancer
- Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to registration
- Prior therapy allowed:
- At least one and no more than 3 platinum based chemotherapy regimens
- Up to 2 non-platinum, cytotoxic regimen
- There is no limit on use of prior biological therapies (hormonal or targeted therapy)
- NOTE: Prior immunotherapy is not allowed
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG), performance status of 0-1 within 14 days prior to registration
- Demonstrate adequate organ function as defined below; all screening labs to be obtained within 14 days prior to treatment initiation:
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (without transfusion or growth factor support/erythropoietin [EPO] dependency)
- Serum creatinine = = 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
- Serum total bilirubin = 1.5 ULN
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = = 2.5 mg/dL
- International normalized ratio (INR) or prothrombin time (PT) = 12 months)
- FOCBP must have a negative pregnancy test within 7 days prior to registration on study
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Exclusion Criteria
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to registration or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent
- NOTE: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
- NOTE: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- Has had a prior anti-cancer monoclonal antibody (mAb) within 28 days prior to registration or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days registration
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days prior to registration and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemi
Data sourced from ClinicalTrials.gov (NCT02901899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.