New drug combo aims to outsmart Platinum-Resistant ovarian cancer
NCT ID NCT02595892
First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 6 times
Summary
This phase 2 trial tests whether adding an experimental drug called M6620 (berzosertib) to standard gemcitabine chemotherapy helps women with ovarian, fallopian tube, or primary peritoneal cancer that came back after platinum-based treatment. About 70 participants will receive either the combo or gemcitabine alone. The main goal is to see if the combo delays tumor growth longer than standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Berzosertib (M6620) plus gemcitabine
- What this could lead to
- If it works, this combination could slow tumor growth better than standard chemotherapy alone for women with hard-to-treat ovarian cancer.
- What could go wrong
- This is a mid-stage trial with only 70 participants. The added drug may not improve outcomes and could cause more side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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70 people
The number who actually took part.
- Started
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Aug 2016
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically confirmed high grade serous ovarian or primary peritoneal or fallopian tube cancer; platinum resistant disease is defined as progression within 6 months after last platinum regimen * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) with conventional techniques or as \>= 10 mm (\>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; measurable disease by RECIST version (v)1.1 with at least one measurable target lesion * Prior therapy: No line limit but no more than 1 prior regimens in the platinum resistant setting; no prior treatment targeting the ATR/checkpoint kinase 1 (CHK1) pathway and no prior gemcitabine as single agent; hormonal therapies immunotherapy, and antiangiogenic therapies (as single agents) do not count as lines; poly (adenosine diphosphate \[ADP\]-ribose) polymerases (PARP)-inhibitors count as a line of therapy unless given in the maintenance setting; PARP-inhibitors given as maintenance after platinum therapy do not count as a line of therapy; prior carboplatin/gemcitabine is allowed provided that there was no disease progression within 12 months after completion of the carboplatin/gemcitabine regimen; subjects may begin protocol treatment at least 4 weeks or 5 half-lives, whichever is shorter, after their last dose of chemotherapy or hormonal therapy, assuming they are otherwise eligible * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky \>= 70%) * Life expectancy of greater than 6 months * Leukocytes \>= 3,000/mcL (within 2 weeks prior to initiation of study treatment) * Absolute neutrophil count \>= 1,500/mcL (within 2 weeks prior to initiation of study treatment) * Platelets \>= 100,000/mcL (within 2 weeks prior to initiation of study treatment) * Total bilirubin within normal institutional limits (within 2 weeks prior to initiation of study treatment) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal (within 2 weeks prior to initiation of study treatment) * Creatinine =\< upper limit of institutional normal OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (within 2 weeks prior to initiation of study treatment) * Confirmation of availability of a formalin-fixed, paraffin-embedded (FFPE) tumor specimen with adequate tumor tissue (either one paraffin embedded tissue block OR 10 5-micron unstained slides from the block on regular \[non-plus\] slides and 1 hematoxylin and eosin \[H\&E\] slide) * All acute, clinically significant treatment-related toxicity from prior therapy, except for alopecia, must have resolved to grade =\< 1 prior to study entry * At least 4 weeks since major surgery or radiation therapy * The effects of M6620 (VX-970) on the developing human fetus are unknown; for this reason and because deoxyribonucleic acid (DNA) damage inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of study; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * No known hypersensitivity or contraindication to the components of study treatment (M6620 \[VX-970\], gemcitabine) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients with primary platinum refractory disease, defined as progression while first line platinum based chemotherapy * Patients who have had chemotherapy within 4 weeks or five half-lives, whichever is shorter, (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients who have had radiotherapy within 4 weeks * Patients who are receiving any other investigational agents * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; a scan to confirm the absence of brain metastasis is not required * History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 (VX-970) or gemcitabine * M6620 (VX-970) is primarily metabolized by CYP3A4; therefore concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of; patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A (CYP3A4 enzyme) are ineligible; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because M6620 (VX-970) and/or gemcitabine are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M6620 (VX-970) and/or gemcitabine, breastfeeding should be discontinued if the mother is treated with M6620 (VX-970) and/or gemcitabine * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with M6620 (VX-970) and/or gemcitabine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
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Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
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UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
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UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
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University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Two-Drug combo outsmart resistant breast and ovarian cancers?
- Targeted pill aims to halt recurrent ovarian and endometrial cancers
- New hope for Platinum-Resistant ovarian cancer: ONC201 and paclitaxel combo trial launches
- Cancer drug combo tested for rare gene mutation – but trial stopped early
- New targeted therapy shows promise for Tough-to-Treat ovarian cancer
- Engineered immune cells target Hard-to-Treat ovarian cancer