Patients must have recovered from adverse events (toxicities resolved to grade  or less) of prior therapy; patients with immune related toxicities from ipilimumab + nivolumab may continue onto Step  even if still on steroids to control side effects, so long as toxicity has resolved to grade  or less
All non-hematologic treatment related toxicities that are deemed clinically significant by the treating investigator must have resolved to =< grade 
Registration Step   Maintenance: All non-hematologic treatment related toxicities that are deemed clinically significant by the treating investigator must have resolved to =< grade 
Treatment with chemotherapy or investigational drugs within  days prior to the screening visit. Acute toxicities from prior therapy must have resolved to Grade ?  above baseline.
The interval between last nivolumab or pembrolizumab and start of study treatment should be at least  days with no residual anti-PD--related immune toxicities in excess of Grade  severity.
Subjects with Grade  toxicities that are deemed stable or irreversible (e.g. peripheral neuropathy) can be enrolled on a case-by-case basis with prior consultation and agreement with the Sponsor Study Physician.
At least  weeks since the last systemic therapy regimen prior to enrollment. Subjects must have recovered to NCI CTCAE v. Grade  or less from all acute toxicities (excluding Grade  toxicities that are not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the Investigator.
Resolution of treatment-related toxicities
At least  week since the last systemic therapy regimen prior to Cycle  Day . Subjects must have recovered to NCI CTCAE v. . < Grade  from all acute toxicities (excluding Grade  toxicities that are not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the Investigator.
Recovery from prior treatment-related toxicities
Toxicities due to prior therapy must be stable and recovered to =< grade  (except for clinically non-significant toxicities, such as alopecia, nutritional support measures, electrolyte abnormalities, or those not impacting the investigators ability to assess treatment emergent toxicities)
Patients currently receiving other anti-melanoma treatment; toxicities attributable to any prior therapy must have resolved to grade  or better prior to enrollment
Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part of treatment
A minimum of  weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation; in addition, recovery to grade  or less from all reversible toxicities related to prior therapy is required at study entry
All anticancer- and radiation therapy-related toxicities must be completely resolved or downgraded to Grade  or less (neuropathy may be Grade  or less).
Resolution of all chemotherapy or radiation-related toxicities to ? Grade 
>  days from therapeutic radiation or chemotherapy (> weeks from nitrosoureas and mitomycin C) and recovery to (NCI CTCAE v.) Grade ?  from all clinically significant toxicities related to prior therapies.
Resolution of treatment-related toxicities.
All persistent clinically significant toxicities from prior chemotherapy must be less than or equal to grade 
Has been receiving erlotinib, gefitinib, or afatinib for at least  weeks with well-controlled related toxicities less than Grade  in severity at the time of screening period.
Prior treatment-related toxicities that have not resolved to ? Grade  before the date of study drug administration except for stable chronic toxicities (? Grade ) not expected to resolve (eg, stable Grade  peripheral neurotoxicity).
Has significant toxicities from prior treatment that have not resolved or stabilized
All prior treatment-related toxicities resolved to =< grade  or are determined to be clinically stable by the investigator
Patients with active infection, un-resolving more than grade  transplant-related toxicities
Baseline toxicities from prior anti-cancer treatments > grade 
Has clinically significant toxicities from previous anti-cancer therapy that have not resolved, or have not stabilized at a new baseline
PHASE I: A minimum of  weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation; in addition, recovery to grade =<  from all reversible toxicities related to prior therapy is required at study entry
If the patient has been using the Optune device, it will be discontinued before initiating treatment with either study medication, and per inclusion criterion listed above, the patient must have recovered from all treatment-related toxicities to Grade  or less.
Prior auto graft is allowed prior to study start (st dose of study medication), but patients must be at least  months from date of stem cell infusion and have recovered to =< grade  toxicities related to this procedure
Non-hematological toxicities ? Grade 
Patients must have recovery from other clinically significant, non-hematologic toxicities to =< grade 
All prior treatment-related toxicities must be =< grade 
Persistent toxicities >= grade  from prior chemotherapy or biological therapy regardless of interval since last treatment
Treatment-related toxicities from prior therapies must have resolved to grade =< 
Treatment-related toxicities from prior therapies must have resolved to grade equal to or less than 
Treatment with chemotherapy or investigational drugs within  days prior to the screening visit. Acute toxicities from prior therapy must have resolved to Grade ?  above baseline.
Hydroxyurea may be used to control leukocytosis and can be taken until day  of therapy; patients with persisting, non-hematologic, non-infectious toxicities from prior treatment =< grade  are eligible, but must be documented as such
ENROLLMENT: Patient must have fully recovered (i.e. returned to baseline) from the clinically significant acute treatment-related toxicities of all prior treatments prior to beginning treatment on this protocol with exceptions of cytopenias resulting from persistent disease, hearing loss and alopecia.
Clinically significant toxicities from prior chemotherapy must not be greater than grade 
Prior treatment with an investigational agent is allowed but must have been completed >=  days prior to randomization with resolution of all treatment-related toxicities to grade =< .
Prior radiotherapy must be completed >=  days prior to randomization with documentation of adequate recovery from associated toxicities to grade =< 
Resolution of chemotherapy, immunotherapy or radiation-related toxicities.
Major surgery within  weeks of starting study treatment; effects from surgeries should have recovered to =< grade , with the exception of stable chronic grade  that is not overlapping with presumed toxicities of olaparib
Persistent toxicities >= grade  from prior chemotherapy or biological therapy regardless of interval since last treatment
Recovery to =< grade  toxicities associated with prior therapy
Any other concurrent illness which in investigators opinion puts the patient at excessive risk of treatment related toxicities
Or known cases of drug-induced hepatobiliary toxicities.
Recovery to from toxicities related to any prior treatments.
Cytotoxic chemotherapy or radiotherapy within  weeks prior and any encountered treatment-related toxicities (excepting alopecia) not resolved to Grade  or less [Phase ] or Grade  or less [Phase ].
Monoclonal antibodies within  weeks prior and any encountered treatment-related toxicities not resolved to Grade  or less [Phase ] or Grade  or less [Phase ].
Investigational drugs (small molecules or biologics) within the longer of  weeks or  half-lives prior to study treatment and any encountered treatment-related toxicities not resolved to Grade  or less [Phase ] or Grade  or less [Phase ].
Acute toxicities of prior treatments and procedures not resolved to grade ?  or baseline before randomisation.
Toxicities related to biopsy must have resolved prior to proceeding with radiation therapy.
All treatment-related or radiation-related toxicities resolved to Grade  or lower
Baseline toxicities from prior anti-cancer treatments > grade 
If the patient has been using the Optune device, it will be discontinued at least four days prior to commencing treatment with VAL-, and the patient must have recovered from all treatment-related toxicities to Grade  or less.
Toxicities from prior therapies that have not resolved to grade  or grade 
A minimum of two weeks since last dose of most recent RCC therapy assuming resolution of clinically significant treatment-related toxicities to grade , baseline, or controlled with supportive medications
ELIGIBILITY FOR TREATMENT ON ARM : Patients treated with prior immunotherapy including and not limited to vaccines, cytokines, T cell stimulating agents, cytotoxic T lymphocyte antigen  (CTLA) inhibitors and programmed death (PD)- check point inhibitors are allowed on therapy provided they did not have any severe grade  toxicities due to prior therapy and any toxicities due to prior therapy should have resolved, if resolvable to less than or equal to grade 
Toxicities related to prior therapy must either have returned to =< grade , baseline, or deemed irreversible
Toxicities related to prior therapy must either have returned to =< grade , baseline or deemed irreversible
Recovery to =< grade  toxicities associated with prior therapy
Grade  or greater toxicities from prior therapy, except for Grade  toxicities that are not expected to resolve and that in the judgment of the Investigator do not pose a significant safety risk to subject participation.
Any >grade  persistent clinically significant toxicities from prior chemotherapy.
Toxicities related to prior therapy must either have returned to =< grade  or baseline or been deemed irreversible and in the opinion of the investigator not worsened
Patients must not have received any chemotherapy within  days of enrollment, and any acute treatment-related toxicities must have returned to baseline; patients may be receiving Hydrea at time of enrollment
Prior radiation to sites other than the brain is allowed, if completed at least  weeks before treatment and provided that all radiation-related toxicities have resolved to =< grade 
Recovery to =< grade  from all significant toxicities of previous therapies
Persistent toxicities >= grade  from prior chemotherapy or biological therapy regardless of interval since last treatment
Participants may have received radiotherapy for palliative purpose, but must not be experiencing > grade  treatment related toxicities, and must have completed treatment >  days prior to registration
Adequate recovery of drug related toxicities, surgery or radiation therapy
?  weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
All clinically significant toxicities from prior chemotherapy must be ? Grade .
The interval from prior treatment to time of study drug administration is at least  week (except for hydroxyurea or steroid therapy) with recovery from all prior therapy-related toxicities
Ongoing toxicities >= grade  from prior therapy
?  weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities
Three or more weeks have elapsed from the completion of previous treatment regimen and subjects must have recovered or be at a new stable baseline from any related toxicities.
?  weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
. All prior cytotoxic toxicities must have resolved to grade ?  prior to randomization.
Resolution of prior treatment associated toxicities to ? grade 
At least  weeks since last cytotoxic chemotherapy, hormonal therapy, or radiotherapy; toxicities related to prior therapy must either have returned to grade , or baseline (excluding alopecia)
Inadequate recovery from any toxicities related to prior treatment (to grade  or baseline)
Prior treatment toxicities must be ? Grade 
Resolution of all prior ONT- related toxicities to ? Grade in severity
Known significant dose delays during prior treatment with a taxane due to drug-related toxicities
Recovery to =< grade  toxicities associated with prior therapy
Clinically significant toxicities from prior chemotherapy must be resolved to Grade ?
All previous therapy-related toxicities must have resolved or return to baseline.
Patients with existing grade  toxicities, except as approved by the investigator
SUBJECT: Must be off anti-neoplastic therapy for at least  weeks and all therapy-related toxicities should return to baseline or =< grade  if previously nonexistent.
Has been receiving erlotinib for treatment of NSCLC with erlotinib-related toxicities well-controlled and less than Grade  in severity at screening
Persistent clinically significant grade >=  toxicities (as per >= CTCAE v) related to prior cancer therapy
Prior treatment with pneumotoxic drugs within past year. If prior therapy in lifetime, then excluded if history of pulmonary toxicities from administration.
All toxicities should recover to grade  or  prior to day 
Has been receiving erlotinib, gefitinib, afatinib, or osimertinib for at least  weeks with well-controlled related toxicities less than Grade  in severity at the time of Screening
Resolution of any clinically significant non-hematological toxicities (if any) from previous treatments to ? Grade  by CD.