Prior immunotherapy with any antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
For subjects who have received prior checkpoint inhibitors:
Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE related to checkpoint inhibitors, not have experienced recurrence of an AE related to checkpoint inhibitors if re challenged, and not currently require maintenance doses of corticosteroids.
Prior exposure to cancer immunotherapy including any immune checkpoint inhibitor and/or cancer vaccines
Refractory to prior checkpoint inhibitor therapy (received less than 6 months of treatment)
Prior treatment with immune checkpoint inhibitors and MEK inhibitors
Prior treatment with any immune checkpoint inhibitor and/or an IDO inhibitor.
Patients must have progressed on prior approved checkpoint inhibitor therapy, not tolerated approved checkpoint inhibitor therapy, or have a contraindication to approved checkpoint inhibitors; patients with stable disease after approved checkpoint inhibitor therapy will also be eligible
Phase II: Subjects who have progressed on first-line systemic therapy (either platinum-based chemotherapy with or without immune checkpoint inhibitor or immune checkpoint inhibitor as first line therapy) who are candidates for second-line systemic therapy.
Phase II: Subjects with an EGFR or ALK mutation who are no longer candidates for TKI therapy and have progressed on standard systemic therapy (either platinum-based chemotherapy with or without immune checkpoint inhibitor or immune checkpoint inhibitor as first line therapy).
Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
Assigned by the physician to receive either docetaxel or immune checkpoint inhibitor per standard of care regimens
For immune checkpoint naïve CRPC patients all of the following must apply:
For immune checkpoint naïve patients all of the following must apply:
For other immune checkpoint naïve tumor cohort all of the following must apply:
Prior exposure to either ipilimumab or combined checkpoint blockade
Patients who have had prior therapy with immune checkpoint inhibition or or indoximod are excluded from the trial.
Known history of allergy or intolerance which, in the opinion of the investigator, was an unacceptable adverse reaction attributed by the investigator to any prior anti-neoplastic therapy specifically targeting T-cell costimulation or immune checkpoint pathways – i.e. nivolumab (Opdivo), pembrolizumab (Keytruda), atezolizumab (Tecentriq), ipilimumab (Yervoy), etc.
Prior treatment with CD137 agonists or immune checkpoint blockade therapies;
History of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapy
Cohort B only: prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy for mCRC.
Prior checkpoint inhibitors/blockade in the last 12 months.
Participants must not have a history of any significant drug allergy (such as anaphylaxis or hepatotoxicity) to prior anti-cancer immune-modulating therapies (eg, checkpoint inhibitors and T-cell co-stimulatory antibodies)
Prior exposure to T cell checkpoint inhibitor therapies.
Previous treatment with and disease progression on a combination of a VEGF inhibitor and an immune checkpoint inhibitor. Patients who have been treated with and have progressed on a single agent VEGF inhibitor OR an immune checkpoint inhibitor will not be excluded
At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy prior to enrollment
Failure to recover from prior side effects of immune checkpoint inhibitor therapy to =< grade 1; NOTE: Patients will not be excluded for adrenal insufficiency or hypothyroidism secondary to immunotherapy provided they are receiving hormonal replacement
No limit is placed on prior systemic treatment, but subjects must be eligible for immune checkpoint inhibitors therapy, for a Food and Drug Administration (FDA) approved indication
Prior treatment with immune checkpoint inhibitors
Ineligible for immune checkpoint inhibitors based on package insert of the chosen immune checkpoint inhibitor (e.g., uncontrolled immunologic disorders, active hepatitis, active colitis, active pneumonitis, uncontrolled/active hormone gland problems - including thyroid, pituitary, adrenal glands and pancreas)
History of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapy
Intolerance to immune checkpoint inhibitor therapy as defined by the occurrence of an adverse drug reaction requiring drug discontinuation (dose escalation cohorts), concurrent anticancer treatment or immunosuppressive agents.
All prior chemotherapy must be at least 4 weeks prior to TATE and free from treatment-related toxicity. No gap is needed for prior PD-1 checkpoint inhibitors in NSCLC patients.
Any cytotoxic chemotherapy, immune checkpoint inhibitor therapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than EGFR TKI), within 14 days of the first dose of study treatment.
Immune checkpoint inhibitor therapy within 30 days of first dose of study treatment.
Failure to respond to standard of care checkpoint blockade therapy or previously responding patients who progress on checkpoint blockade therapy
Patient must have received prior systemic therapy with an immune checkpoint inhibitor (monotherapy or combination) as 1st or 2nd line RCC treatment. Note: patients with prior mTOR inhibitor or TKI treatment as monotherapy or in combination with immune checkpoint inhibitor are allowed; however, treatment with immune checkpoint inhibitor (monotherapy or in combination) must have been the last treatment prior to study entry.
Last dose of immune checkpoint inhibitor therapy must have been received 4 or more weeks before start of study treatment
Prior treatment with bevacizumab that was not given in combination with immune checkpoint inhibitor therapy.
Prior therapy with T-cell therapy, including an immune checkpoint inhibitor
Patients who have had prior exposure to immune checkpoint inhibitors are not eligible; please contact principal investigator, Maria Matsangou at 312-926-4248 for specific questions on potential interactions\r\n* NOTE: Immune checkpoint inhibitors working through OX40 are an exception (for example, MEDI6383, MEDI6469, MEDI0562, oxelumab, and PF-04518600) and are permitted >= 28 days prior to study registration
Previous treatment with immune checkpoint inhibitors
Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
Immunotherapy with immune checkpoint inhibitors, cell-based therapies, or cancer vaccines
Has received prior therapy with any immune checkpoint inhibitor
Prior exposure to T cell checkpoint inhibitor therapies, including durvalumab and tremelimumab
Subjects with disease recurrence or progression After therapy with an immune checkpoint inhibitor and platinum-based chemotherapy i) either 1st line chemotherapy followed by 2nd line checkpoint inhibitor, or ii) 1st line combination of checkpoint inhibitor and chemotherapy
Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
Unacceptable toxicity with prior checkpoint inhibitor
Prior immune-checkpoint inhibitors within 4 weeks (or 8 weeks, if immuno-oncology doublet used as the prior line of therapy)
History of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapy
Known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an AE leading to drug discontinuation;
Prior anticancer therapy is allowed, including prior checkpoint inhibitor treatment.
Prior immunotherapy with checkpoint inhibitors
Any other illness or condition that in the investigator’s opinion would adversely affect the safety of checkpoint inhibitor therapy
Eligible for checkpoint inhibitor immunotherapy (pembrolizumab) per standard of care
Prior immunotherapy with immune checkpoint inhibitors
Previous treatment with talimogene laherparepvec or other herpes virus based therapy; (prior therapy with checkpoint inhibitors and/or other immunotherapy is allowed)
History of grade 3 or 4 bowel toxicity from immune checkpoint inhibitor within 12 weeks of registration
Previous treatment with checkpoint inhibitor drugs
Subjects who have received prior immune checkpoint inhibitors or an IDO inhibitor (except select Phase 2 cohorts evaluating I/O relapsed or I/O refractory MEL). Subjects who have received experimental vaccines or other immune therapies should be discussed with the medical monitor to confirm eligibility
Prior treatment with CD137 agonists or immune checkpoint blockade therapies.
Grade 3 colitis, hepatitis, pneumonitis uveitis, myocarditis, myositis, CNS toxicity or autoimmune related neuromuscular toxicity such as myasthenia gravis associated with the administration of an immune checkpoint inhibitor
Have discontinued previous experimental therapies and checkpoint inhibitor antibodies at least 28 days prior to the Randomization Visit
Subjects who received prior therapy with checkpoint inhibitor
Prior treatment with any drug that targets T cell co-stimulation pathways(such as checkpoint inhibitors)
No prior history of immune checkpoint modulator therapy
Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria
Patients with a history of Grade ?2 gastrointestinal symptoms (e.g., diarrhea, colitis) during prior checkpoint inhibitor treatment should be discussed with the Idera Medical Monitor during the Screening Period before starting study treatment.
Patients in Phase 2 expansion cohort A will have experienced disease progression with 1 systemic treatment containing a checkpoint inhibitor. Any prior liver directed therapy is acceptable.
Has plans to receive cytotoxic chemotherapy, immune checkpoint inhibitors (eg CTLA-4 blockade), sipuleucel-T, radiopharmaceuticals, abiraterone or other experimental therapy during this study period
Prior treatment with any agent specifically targeting T-cell co-stimulation or checkpoint pathways
Prior treatment with clusters of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, systemic immunostimulatory agents, or systemic immunosuppressive medications
Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugs; (immune checkpoint inhibitors that are antibody-based will only require 28 days before enrollment)
Patient receiving any investigational or experimental agents other than checkpoint blockade immunotherapy
Patients previously treated with immune checkpoint inhibitor therapy are eligible
Not a candidate for treatment with an immune checkpoint inhibitor (e.g., failed or did not tolerate prior therapy, or due to co-morbidities, pre-existing autoimmune disease, drug unavailability or standard of care)
Prior treatment with CD137 agonists or immune checkpoint blockade therapies
Immune therapy (monoclonal antibody therapy, checkpoint inhibitors) within 4 weeks.
Any previous immunotherapy with immune checkpoint inhibitors such was nivolumab, atezolizumab and others in the class.
Patients with prior immune checkpoint inhibitors must have related toxicities reduced to Grade 0, 1, or baseline
Prior treatment with CD137 agonists or other immune checkpoint blockade therapies, including anti-CTLA-4 therapeutic antibodies
Prior history of Grade 3 or greater drug-related diarrhea/colitis during treatment with checkpoint inhibitors or other immunotherapy treatments.
Has had prior monoclonal antibody (mAb) targeting immune checkpoint proteins, for distant metastatic melanoma and have progressed or have developed intolerable side effect
Patients who are eligible to receive combined dual immune-checkpoint blockade therapy with ipilimumab and nivolumab, per referring oncologist
Candidate to undergo immune checkpoint inhibitor (ICI) therapy for SCLC or NSCLC (ICI as any line of chemotherapy is acceptable) as deemed by individual’s treating oncologist
Immune checkpoint inhibitor therapy within 30 days of the first dose of study treatment
Patients must have relapsed/refractory disease, with at least one line of prior chemotherapy, but =< 2 prior lines of treatment, for Hodgkin lymphoma; NOTE: patients must not have had prior immune checkpoint inhibitors; however, there are no other limitations to prior agent or regimen types
Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
Prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anticancer therapy for the treatment of (limited or extensive) SCLC.