Comparing 6 approaches for ovarian cancer

Exclusion

• −Patients with a known hypersensitivity to study intervention or any of the excipients of the product.
• −Active infection, including tuberculosis and infections with hepatitis B virus (HBV; verified by known positive hepatitis B surface antigen \[HBsAg\] result), hepatitis C virus (HCV) or known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥ 350/mm3, no history of acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen).
• −Patients with spinal cord compression or a history of leptomeningeal carcinomatosis.
• −Patients with brain metastases unless, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to first dose of study intervention.
• −Patients with a past or resolved HBV/HCV infection are eligible if:
• −Negative for HBsAg and positive for anti-hepatitis B virus core protein (HBc) or
• −Are HBsAg + with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below:
• −(i) HBV DNA viral load \<100 IU/mL. (ii) Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \<3 x upper limit of normal (ULN), which are not attributable to HBV infection.
• −(c) Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction test result is negative for HCV RNA.
• −Treatment with any of the protocolProtocolThe detailed plan a study must follow.Read more → defined medications, without adequate washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → periods or time before the first dose of study intervention.
• −(iii) Start or maintain antiviral treatment if clinically indicated as per the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → or as per local guideline.
• −Note for Japan: Japanese patients with positive anti-HBs/anti-HBc and negative HBsAg will be assessed following local guidelines.
• −Patient has active ILD/pneumonitis or has a history of (non-infectious) ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −History of another malignancy except for:
• −Malignancy treated with curative intent and with no known active disease for at least 2 years prior to screening of study intervention and with low potential risk for recurrence.
• −Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• −Adequately treated carcinoma in situ without evidence of disease.
• −Localized non-invasive solid organ primary disease under surveillance.
• −Patients with any of the following cardiac criteria:
• −History of arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, and ventricular tachycardia), which is symptomatic or requires treatment NCI CTCAE v5.0 Grade 3 except for:
• −(i) Rate controlled asymptomatic atrial fibrillation.
• −NOTE: significant abnormalities in serum electrolytes that can increase the risk of arrhythmic events (ie, sodium, potassium, calcium, and magnesium) should be corrected before starting the study intervention.
• −Uncontrolled hypertension.
• −Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months of screening.
• −History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.
• −Symptomatic heart failure (as defined by New York Heart Association class ≥ 2).
• −Prior or current diagnosis of cardiomyopathy considered clinically relevant per investigator's judgement.
• −Severe uncorrected valvular heart disease.
• −Mean resting QTcF \> 470 msec obtained from triplicate electrocardiograms (ECGs) and averaged, recorded within 5 minutes.
• −Any factor that, in the opinion of the investigator, increases the proarrhythmic risk of QT prolongation, such as congenital long QT syndrome, family history of long QT syndrome, hypertrophic cardiomyopathy, or unexplained sudden cardiac death under 40 years of age.
• −Uncontrolled and/or unresolved intercurrent illness within 12 months prior to screening, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, or illness (including psychiatric illness) and/or social situations, in the opinion of the investigator, that would limit compliance with study requirements and activities, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• −Substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the Investigator.
• −Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants, if enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more →, should not receive live vaccine whilst receiving study intervention and up to 3 months after the last dose of study intervention. Participants can receive Coronavirus (COVID)-19 vaccines, at the discretion of the Investigator, following a benefit/risk evaluation for the individual participant and in accordance with local rules and regulations and vaccination guidelines. Note: If a COVID-19 vaccine is administered it should be done \> 72 hours prior to study intervention initiation or after completion of the DLT period.
• −Concurrent enrolment in another clinical study, unless it is an observationalObservational studyA study that watches what happens without assigning any treatment.Read more → (non interventionalInterventional studyA study where participants are given something to see what happens.Read more →) clinical study or during the follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → of an interventional study. Exception: Diagnostic imaging evaluation studies (e.g. PET) may be allowed subject to case-by-case discussion with the SponsorSponsorThe organisation responsible for the study overall.Read more →.
• −Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study siteTrial siteA hospital or clinic where a study is actually run.Read more →).
• −Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
• −Previous enrolment in the present study. \*\*Other module specific criteria may apply
• −For women only - currently pregnant (confirmed with positive pregnancy test or suspected), lactating, breastfeeding, or intention to become pregnant during the study period.
• −Unresolved toxicities of Grade ≥ 2 (National Cancer Institute \[NCI\] CTCAE v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). Participants with stable ≤ Grade 2 neuropathy are eligible.
• −Patients with a history of radiation pneumonitis which has clinically and radiologically resolved and not requiring treatment with steroids may be eligible.