Must either have prior treatment with platinum-containing chemotherapy (Cohort ) or be platinum-nave and ineligible for treatment with cisplatin at time of enrollment (Cohort ).
Patient must have developed disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine/cisplatin [GC], methotrexate-vinblastine-doxorubicin-cisplatin [MVAC], carboplatin, gemcitabine [CarboGem]) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence, or must be unfit or ineligible for cisplatin-based chemotherapy; there is no restriction on the number of prior lines of chemotherapeutics agents received\r\n* Patients who progressed within months of treatment with a platinum-containing neoadjuvant or adjuvant regimen are considered second-line patients; therefore, these patients may be also eligible\r\n* Patients who are unfit or ineligible for cisplatin-based chemotherapy as defined by any one of the following criteria are eligible for this trial: \r\n** Eastern Cooperative Oncology Group (ECOG) performance score of \r\n** Creatinine clearance < mL/min \r\n** A hearing loss (measured by audiometry) of dB at two contiguous frequencies \r\n** Grade >= peripheral neuropathy
Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)
Maintenance or switch maintenance therapy after first-line chemotherapy will be considered part of the first-line regimen and is acceptable. Participants who completed and progressed on a platinum-containing regimen as adjuvant, neoadjuvant, or part of a course of chemoradiation therapy given from locally advanced disease and developed recurrent (local or metastatic) disease within the months before screening would be counted as having received prior platinum-containing regimen and therefore would not require re-treatment with a platinum-containing regimen for Stage IIIB, IV, or recurrent disease and are eligible. However, participants must have received at least cycles of a platinum doublet based chemotherapy before discontinuation for toxicity. If participants received only one cycle of a platinum doublet and discontinue due to clear progression, that regimen should be counted as a prior line of therapy.
Second-line patients who have disease progression during or following platinum-containing chemotherapy.
Have progression during or following platinum-containing chemotherapy or within months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Platinum resistance, defined as disease progression within months of completing a platinum-containing chemotherapy regimen. For NSCLC
Radiologic evidence for progressive disease after >= prior platinum containing chemotherapy regimen in the perioperative or metastatic setting
Must have received prior platinum containing chemotherapy for advanced/metastatic non-small cell lung cancer, or have refused or be ineligible for such therapy; prior neoadjuvant/adjuvant platinum containing chemotherapy will count has having received prior platinum, provided that disease recurred within months of completion of neoadjuvant/adjuvant therapy
Platinum-resistant or platinum-refractory disease, defined as either ) less than a complete response to the most recent carboplatin- or cisplatin-containing chemotherapy regimen, ) serum cancer antigen (CA)- >= x upper limit of normal (ULN) within days of last dose of carboplatin- or cisplatin-containing chemotherapy, confirmed by a second CA- (the second CA- does not have to be within days of chemotherapy), or ) CT or positron emission tomography (PET)/CT evidence of cancer recurrence within days of last dose of carboplatin- or cisplatin-containing chemotherapy
Evidence of progressive disease (PD) on or within months of a platinum (cisplatin or carboplatin) regimen: at least prior regimen must have contained a platinum-taxane combination
Subjects must have progression of disease within months of platinum-containing chemotherapy (chemotherapy could have been given in the neoadjuvant, adjuvant or metastatic settings) for urothelial cancer
Prior progression on only line of chemotherapy in the advanced/metastatic setting containing a fluoropyrimidine and/or platinum compound
Progression after treatment with least one platinum containing chemotherapy regimen
Histologically confirmed metastatic non-small cell lung cancer (NSCLC) with disease recurrence or progression during or after prior platinum-containing doublet chemotherapy regimen
Either ineligible for first-line cisplatin-based chemotherapy or have disease progression during or following treatment with at least one platinum-containing regimen.
Patient has received prior treatment with AM or fluoropyrimidine/platinum containing regimen
Must have received at least one line of standard systemic treatment for locally advanced or metastatic disease setting of the respective tumor type; for NSCLC, it is either PD-/PD-L inhibitor, or platinum-containing chemotherapy, or an EGFR tyrosine kinase inhibitor or an ALK inhibitor if sensitizing mutation present; TNBC: platinum-containing chemotherapy; PDAC: fluorouracil (-FU-), gemcitabine-, or taxane-containing chemotherapy either with or without radiation therapy; SCLC: platinum-containing chemotherapy for limited or extensive stage disease
For subjects in Group A with neuroendocrine prostate cancer (NEPC), previous use of at least one platinum-containing chemotherapy regimen
Patients with ovarian cancer can be platinum-sensitive (with documented progression > months after completion of a platinum containing regimen) or platinum resistant (progression < months after completion of a platinum containing regimen)
Phase I/IB (pre-treated): have progression from at least one prior line of therapy; maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy; subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within months of completing therapy are eligible for these arms; subjects with recurrent disease >= months after completing a platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a systemic regimen given to treat the recurrence, must have received another treatment in the first-line metastatic setting
Prior progression on or within weeks of the last dose of a platinum agent (i.e. cisplatin or carboplatin) for recurrent or metastatic disease
Adults with histologically proven solid tumor for which a PD- or a PD-L agent is indicated:\r\n* Non-small cell lung cancer who has failed at least treatment regimen for metastatic or recurrent disease; patients must have received a prior platinum-containing regimen\r\n* Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy\r\n* Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who had disease progression on or after platinum-containing chemotherapy or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy\r\n* Advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic agent\r\n* Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V mutation positive, a BRAF inhibitor
Disease progression on platinum-doublet chemotherapy prior to enrollment
Disease Status: For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including or more agents that must include an alkylating agent and a platinum-containing compound. Patients must have ONE of the following:
progression or relapse during or within months of the most recent treatment with a platinum-containing chemotherapy regimen
Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least cycles). In patients who received prior adjuvant/neoadjuvant platinum-containing chemotherapy, progression had to occur within months of treatment.
Subject has experienced disease progression on or after platinum-containing chemotherapy
Participants must have recurrence within months of their last platinum-containing regimen
Must have progression on or after therapy containing platinum/fluoropyrimidine or refused standard therapy.
Had disease progression while on a platinum containing regimen in the first-line setting or within months after completing the first-line platinum regimen. Participants who received treatment with one immune checkpoint inhibitor regimen are eligible (for example PD-, PDL, or CTLA) and may have a longer interval since prior platinum-containing therapy (? months).
Patients must have previously received a platinum and paclitaxel containing regimen
Has received prior therapy with at least platinum-containing regimen
Documented progressive disease according to RECIST v. (Appendix ) following receipt of at least cycles of one platinum-containing chemotherapy regimen administered for R/M disease (min. mg/m for cisplatin, minimum area under the curve [AUC] > for carboplatin).
Progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. A participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ? months following completion of therapy.
Subjects with recurrent disease > months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
Prior chemotherapy: Cohort ) PR or CR to prior platinum-containing regimen for metastatic disease with disease progression > weeks following the last dose of platinum; or Cohort ) > prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease
Received no more than non-platinum chemotherapy regimen. Prior hormonal therapy will not be counted as a non-platinum regimen.
Radiographic progression after treatment with at least cycles of a platinum-containing doublet
i) With at least platinum-containing chemotherapy regimen for metastatic or surgically unresectable locally advanced urothelial cancer, or
Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine doublet
Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence
Patients must have previously received, not tolerated, or been judged clinically unsuitable for platinum-containing therapy
Progression or recurrence of urothelial cancer following a first-line platinum-containing regimen (e.g cisplatin, carboplatin) for metastatic or inoperable locally advanced disease; or adjuvant platinum-based therapy following cystectomy for localized muscle-invasive urothelial cancer with recurrence/progression <= months following completion of therapy; or neoadjuvant platinum-containing therapy prior to cystectomy for localized muscle-invasive urothelial cancer with recurrence <= months following completion of therapy
Tumor progression or recurrence during or after treatment with only systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent.
Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], CarboGem, etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence.
A regimen was defined as participants receiving at least two cycles of a platinum-containing regimen. Participants who had received one cycle of a platinum-containing regimen but discontinued due to Grade hematologic toxicity or Grade or non-hematologic toxicity could also be eligible.
Patients who have received at least previous lines of platinum containing therapy prior to randomisation For the penultimate chemotherapy course prior to enrolment on the study: Patient defined as platinum sensitive after this treatment; defined as disease progression greater than months after completion of their last dose of platinum chemotherapy For the last chemotherapy course immediately prior to randomisation on the study:
Patients who have completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation:
Patient has received at least one prior platinum-containing (cisplatin or carboplatin) regimen
Subjects initially treated with a platinum regimen for Stage IIIB disease who later develop metastatic disease and are re-treated with a platinum regimen are allowed.
Stage IV locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy or had disease progression within months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
Recurrent or refractory disease after receiving at least one prior standard/approved platinum-containing chemotherapy regimen, or where standard therapy is refused. Part only: Subjects must have recurrent disease after receiving a maximum of two prior chemotherapy regimens including at least one platinum containing regimen.
Participants must have received prior platinum-based chemotherapy regimen (excluding a docetaxel-containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) disease followed by documented progressive disease (PD).
Patients must have received prior platinum containing doublet regardless of mutation status
Patients must have received prior platinum containing treatment.
Recurrent platinum-sensitive disease, defined as disease progression ? months after completing a minimum of cycles of a platinum-containing regimen
Disease that has progressed or relapsed during or within months after the most recent treatment with a platinum-containing chemotherapy regimen
Completed line of chemotherapy treatment with a platinum-containing regimen in the advanced setting
Has responded to last the platinum regimen, remains in response and is enrolled on study within weeks of completion of the last platinum regimen
platinum-resistant cancer, defined as disease that responded to a platinum-containing chemotherapy regimen, but demonstrated recurrence within six months following the completion of that platinum-containing regimen, OR
platinum-refractory cancer, defined as disease failed to achieve at least a partial response to a platinum-containing regimen (i.e., stable disease or actual disease progression), AND
Participants must have recurrent or refractory disease after receiving at least one prior platinum-containing chemotherapy regimen, or standard therapy is refused or not suitable. For participants in Canada: participants should also not be suitable for treatment with topotecan hydrochloride
Subject has experienced disease progression or unacceptable toxicity/intolerance after receiving at least systemic platinum-containing regimen;
Failed treatment with one regimen containing at least a platinum/fluoropyrimidine doublet for unresectable or metastatic disease.Treatment failure is defined as progression of disease (clinical or radiologic) during first line treatment for unresectable or metastatic disease or ? months after last dose of first line treatment.
Subjects must have platinum resistant disease (i.e., which is defined as disease progression in less than months after receiving a minimum of cycles of a platinum containing regimen).
At least prior regimen must have contained a platinum salt
Progression during or after treatment with a regimen that includes a platinum salt (e.g., carboplatin or cisplatin) OR
Up to patients with metastatic colorectal cancer with a history of progression or recurrence following prior fluoropyrimidine, irinotecan and platinum containing regimens as well as bevacizumab. In addition, patients with Kras wild type tumor must have received at least one EGFR blocker.
Squamous Cell Carcinoma of the Cervix (SqCC) All patient with Squamous Cell Carcinomas should have a documented history of progression or recurrence following at least one prior platinum based chemotherapy or chemotherapy/radiation containing regimen
Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with - cycles of Bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of cycles of Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease
must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
Recurrent or metastatic disease that has been treated with at least one platinum-containing regimen and lacking a curative treatment option.
Any prior chemotherapy is allowed including prior treatment with platinum-containing chemotherapy
Disease must have progressed after treatment with a platinum-containing regimen and should be defined as one of the following: i. disease progression or recurrence between to months of prior curatively intended multimodal therapy (which includes platinum therapy) for locoregionally advanced SCCHN. ii. disease progression or recurrence after prior platinum therapy in the recurrent or metastatic setting Note: This criterion is only applicable for subjects who have not had treatment in the recurrent/metastatic setting