Patients must not have any history of locally advanced or metastatic cancer requiring systemic therapy within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer; patients must have no previous primary lung cancer diagnosed concurrently or within the past 2 years No history of other malignancy within the past 4 years, except for malignancies with a > 95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer); patients cannot have metastatic breast or other cancer Diagnosed with or treated for cancer within the previous 2 years, other than breast cancer or non-melanoma carcinoma of the skin. History of any other malignancies in the last 2 years except in-situ cancer, non-muscle invasive bladder cancer, basal or squamous cell skin cancer are eligible Active, concurrent malignancy requiring radiation, chemotherapy, or immunotherapy (excluding non-melanoma skin cancer, adjuvant hormonal therapy for breast cancer and hormonal treatment for castration sensitive prostate cancer). Other active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 2 years after completion of treatment) Individuals with a history of an active malignancy (other than the current lung cancer diagnosis) within the last 3 years (except non-melanoma skin cancer or a non-invasive/in situ cancer) Other invasive cancer diagnosis within the past 5 years other than non-melanoma skin cancer Women with previous history of cancer (including invasive or intra-ductal breast cancer) except for non-melanoma skin cancer. History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years;\r\n* Exceptions: non-melanoma skin cancer and in situ cervical cancer Participant has a history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) active within 18 months prior to the baseline study visit; (participants who have a history of cancer that was curatively treated without evidence of recurrence in the 18 months prior to the baseline study visit are considered eligible) Active, concurrent malignancy requiring radiation, chemotherapy, or immunotherapy (excluding non-melanoma skin cancer, adjuvant hormonal therapy for breast cancer and hormonal treatment for castration sensitive prostate cancer). Patients with a history of any other invasive cancer (except non-melanoma skin cancer and excluding carcinomas in-situ), unless in complete remission and off of all therapy for that disease for >= 3 years, are ineligible Prior malignancy requiring therapy within the last 12 months (excluding non-melanoma skin cancer); hormone therapy for prostate cancer or adjuvant endocrine therapy for breast cancer would not be excluded Other active malignancy within the last 3 years (except for non-melanoma skin cancer, a non-invasive/in situ cancer, or indolent non metastatic Gleason 6 prostate cancer) Currently active second malignancy or past history of malignancies diagnosed within the last 5 years that require active therapy and/or in remission with life expectancy of < 5 years, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer Has any other malignancy diagnosed within 2 years of screening with the exception of basal or squamous cell skin cancer, or non-invasive cancer of the cervix, or any other cancer deemed by the treating physician to be of low-risk for progression or patient morbidity during the study period. Patients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or localized prostate cancer for whom systemic therapy is not required) Other concurrent cancer (with the exception of non-melanoma skin cancer and low-risk localized prostate cancer on active surveillance) Diagnosis of other invasive malignancies within the preceding 3 years prior to screening with > 30% likelihood of relapse within the next 3 years, except non-melanoma skin cancer and non-muscle invasive urothelial cancer Patients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or localized prostate cancer for whom systemic therapy is not required) Invasive solid tumor within 5 years; non-melanoma skin cancer or in situ malignancies are allowed Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five years Other primary tumor (other than castration-resistant prostate cancer [CRPC]) including hematological malignancy present within the last 5 years (except non?melanoma skin cancer or low?grade superficial bladder cancer) Have been diagnosed with another cancer or myeloproliferative disorder in the past 5 years except for superficial bladder cancer, non-melanoma skin cancers, or a low grade prostate cancer not requiring therapy ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Have been diagnosed with another cancer or myeloproliferative disorder in the past 5 years except for superficial bladder cancer, non-melanoma skin cancers, or a low grade prostate cancer not requiring therapy The subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an early form of cervical cancer, or another cancer diagnosed >= 2 years previously) and currently has no evidence of active other malignancy (unless non-melanoma skin cancer or an early form of cervical cancer) No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers from which the subject has been disease-free for at least 2 years History of other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years No history of unrelated (non-lymphomatous) neoplasms within past 5 years other than non-melanoma skin cancer or in-situ cancer Other known co-existing malignancies except non-melanoma skin cancer unless definitively treated and proven no evidence of recurrence for 5 years. Concurrent cancer of any other type except skin cancer (excluding melanoma) Previous (within the past 5 years) or concurrent presence of other cancer, except non-melanoma skin cancer and in situ carcinomas. Evidence of invasive anal, vulva, vaginal, or cervical carcinoma; prior loop electrosurgical excision procedure (LEEP) or ablative treatment within 6 months prior to study entry; other invasive malignancies, with the exception of non-melanoma skin cancer, within the last 5 years Other active malignancy within the last 3 years (except for non-melanoma skin cancer, a non-invasive/in situ cancer, or indolent nonmetastatic Gleason 6 prostate cancer) Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment They must not have undergone treatment for any other form of cancer (aside from non-melanoma skin cancer) in the past five years Nonmelanomatous skin cancer. Any active malignancy, other than RCC, for which chemotherapy or other anti-cancer therapy is indicated. Patients with adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 3 years will be permitted. Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years Other clinically significant malignant disease diagnosed within the previous 5 years, excluding intra-epithelial cervical neoplasia or non-melanoma skin cancer. Must not have other invasive malignancies within the past 3 years (with the exception of non-melanoma skin cancers or non-invasive bladder cancer). Other invasive malignancies within the last 3 years, except non- melanoma skin cancer and localized cured prostate and cervical cancer; History of other malignancies, other than non-melanoma skin cancer, Ta or T1 (low grade) bladder carcinomas, or other low grade cancer of very low clinical impact, unless in complete remission and off therapy for that disease for at least 2 years Prior history of invasive cancer within 5 years before screening, except for adequately treated in situ carcinomas or non-melanoma skin cancer Active invasive cancer other than the one of the three cancers in this study; patients with active non-invasive cancers (such as non-melanoma skin cancer, superficial cervical and bladder and prostate cancer with PSA level < 1.0) are not excluded History of concurrent or previously non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/= 5 years History of non-prostate, primary, malignant cancer, except for non-melanoma skin cancer within previous five years Diagnosed with or treated for cancer within the previous two years, other than breast cancer or non-melanoma carcinoma of the skin Patients with concurrent malignancies or malignancies within 3 years prior to starting study drug (with the exception of tumors common to a single genetic cancer syndrome, i.e. MEN1, MEN2, von Hippel-Lindau [vHL], tuberous sclerosis complex [TSC] etc., or adequately treated, basal cell skin cancer, squamous cell carcinoma, non-melanoma skin cancer or curatively resected cervical cancer) Other coexisting malignancies or malignancies diagnosed within the previous 3 years no evidence of disease for at least 3 years; exceptions to this include non-melanoma skin cancer, cervical cancer in situ, well differentiated thyroid cancer or prostate cancer; other cancers that per assessment of the PI are not prognosis limiting can be allowed after review by the PI Concurrent untreated cancer excluding non-melanoma skin cancer Previous malignant disease within the last 5 years with the exception of adequately treated non-melanoma skin cancer, in situ cancer, or other cancer Patients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers, non-invasive bladder cancer or localized prostate cancer for whom systemic therapy is not required) History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early state prostate cancer, or curatively-treated cervical cancer in-situ. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five years Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) < 5 years from their new diagnosis of cervical cancer Treatment for other carcinomas within the last two years, except cured non-melanoma skin, low-risk prostate cancer, non-invasive bladder cancer, or treated in-situ cervical cancer Malignancies within the past 5 years other than non-melanoma skin cancer or in situ cervical cancer status post treatment Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment Patients must not have other invasive malignancies within the past 3 years (with the exception of non-melanoma skin cancers, localized prostate cancer, carcinoma in situ of the cervix and non-invasive bladder cancer that has had successful curative treatment) Patients must not have other invasive malignancies within the past 5 years (with the exception of non-melanoma skin cancers or non-invasive bladder cancer) No history of a previous invasive cancer in the last five years with the exception of minimally invasive non-melanoma skin cancer. History of other invasive cancer in the previous 5 years other than minimally invasive non-melanoma skin cancer. No concurrently active second invasive malignancies except non-melanoma skin cancer Patient has a concurrent diagnosis of a another cancer (other than non-melanoma skin cancer) and is in active treatment for it Partner is also diagnosed with cancer (other than non-melanoma skin cancer) and is in active treatment for it Other active malignancies requiring oncologic treatment (Note: non-melanoma skin cancer, superficial bladder cancer, etc. are eligible) Other cancers (excluding non-melanoma skin cancer) diagnosed within 5 years prior to index lesion, including concurrent invasive cancer diagnosis and up to the present time of participant’s approach to invitation into the study Prostate cancer and a personal history of prior malignancy that does not include non-melanoma skin cancer or superficial bladder cancer Partner cannot have cancer diagnosis (other than non-melanoma skin cancer) and be currently receiving treatment Personal diagnosis of any cancer, other than non-melanoma skin cancer PHASE 2: PATIENT EXCLUSION CRITERIA: Patients with cancer diagnoses that are not typically considered pediatric cancer, including basal and squamous cell skin cancer, breast, colorectal, lung, melanoma, merkel cell skin cancer, ovarian, testicular, kidney cancer diagnosed at age > 17, and nasopharyngeal diagnosed at age > 17 PHASE 3A/3B: PATIENT EXCLUSION CRITERIA: Patients with cancer diagnoses that are not typically considered pediatric cancer, including basal and squamous cell skin cancer, breast, colorectal, lung, melanoma, merkel cell skin cancer, ovarian, testicular, kidney cancer diagnosed at age > 17, and nasopharyngeal diagnosed at age > 17 Any other cancer present within the last 5 years (other than gynecologic cancer under study and non-melanoma skin cancer) Past history of any cancer other than non-melanoma skin cancer Not have been treated for other cancer (except non-melanoma skin cancer) in the past 5 years Active cancer defined as metastatic disease and/or any evidence of cancer on cross-sectional or positron emission tomography (PET) imaging, cancer related surgery, chemotherapy or radiation therapy within the past 6 months; note: non-melanoma skin cancer does not meet the cancer requirement Prior history of cancer (other than skin cancer); Previous treatment of any cancer excluding skin cancer Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus Active cancer defined as metastatic disease and/or any evidence of cancer on cross-sectional or positron emission tomography (PET) imaging, cancer related surgery, chemotherapy or radiation therapy within the past 6 months; Note: non-melanoma skin cancer does not meet the cancer requirement Invasive cancer within the past five years except non-melanoma skin cancer Women with a history of any cancer within the last 3 years, except for non-melanoma skin cancer; history of breast cancer must be at least > 5 years from diagnosis History of cancer (except for non-melanoma skin cancer) Individuals with any history of cancer other than non-melanoma skin cancer Evidence of other cancer(s) (excluding non-melanoma skin cancer) within last 5 years Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer New cancer diagnosis in the last six months (with the exception of non-melanoma skin cancer) Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the Study Any type of active invasive cancer (excluding breast and non-melanoma skin cancer) within the preceding 18 months Diagnosis of any cancer (except non-melanoma skin cancer) Invasive cancer within the past five years except non-melanoma skin cancer With a history of another cancer, except for non-melanoma skin cancer, as per medical records or patient report Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years No prior treatment within 5 years for another cancer, including chemotherapy, surgery (except for diagnostic biopsy), radiation therapy, hormonal therapy or investigational agents, unless curative treatment of non-melanoma skin cancer or in situ cancer Any previous diagnosis of cancer except for non-melanoma skin cancer History of any cancer, other than non-melanoma skin cancer (Arm 4)