Patients must have at least one lesion that has not previously been irradiated (and is not within a previously radiated field) and for which palliative radiation is potentially indicated and could be safely delivered at the radiation doses specified in this protocol; this lesion must not be the only measurable lesion so that it is still possible to determine the response rate outside of the radiation treatment field; this lesion must not be within the central nervous system (CNS) (brain or spinal cord) or requiring urgent or emergent palliative radiation given the timing of radiation specified on this protocol; furthermore, this lesion: \r\n* For cohort 1 (NSCLC cohort) – the lesion to be irradiated must be in the lung, lymph nodes, adrenal gland or liver \r\n* For cohort 2 (colorectal cohort) – the lesion to be irradiated must be in the liver
Must have at least 1 lesion with measurable disease
At least 1 measurable lesion for solid tumor
Presence of measurable disease based on RECIST 1.1; subjects with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
Tumor lesion accessible for biopsy after the start of treatment. (Note: this lesion should be separate from measurable lesions that will be used for response assessment.)
Presence of at least one measurable lesion as defined by RECIST version (v)1.1; a previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the completion of irradiation
For the MTD expansion cohort, Subject must have an accessible tumor lesion(s) and consent to tumor biopsy of such a lesion(s) during screening and after starting KO-947 treatment.
The patient must have multiple sites of metastatic disease with at least one lesion amenable to treatment with stereotactic radiation therapy (SBRT) in the lung or liver and at least one lesion not being irradiated and meeting RECIST 1.1.
COHORT A: Measurable CNS disease (one intracranial lesion >= 5 mm)
COHORT B: Measurable CNS disease (one intracranial lesion >= 5 mm)
COHORT D: Measurable CNS disease (one intracranial lesion >= 5 mm) from any solid tumor
Measurable disease in the brain, defined as at least 1 lesion measuring >= 5 mm on imaging at the time of registration
Patients who underwent neurosurgery (NSGY), whole brain radiation therapy (WBRT), or stereotactic radiosurgery (SRS) to a brain lesion must have a new measurable lesion; previously surgically excised lesion/tumor bed, may be used as a measurable lesion if disease has progressed since surgery (NOTE: SRS may be done to a lesion that will not be used for response evaluation and should be done > 2 weeks prior to registration; any WBRT must have occurred > 60 days ago; any NSGY procedure must have been completed > 3 weeks prior to registration and baseline imaging)
Primary breast tumor size at least 2 centimeter (cm) in one dimension by clinical or radiographic exam; patients who have multicentric breast cancer are eligible if each lesion is ER-negative and HER2-negative; in that case, one lesion needs to be identified as the index lesion to be followed for clinical response; the index lesion must also be the lesion from which core biopsies are obtained
At least one measurable lesion.
Lesion must be sonographically visible at the time of treatment.
At least one measurable lesion as defined by RECIST version (v)1.1 criteria; previously irradiated lesions are not measurable unless the lesion has demonstrated clear progression after radiation
At least 1 measurable lesion that can be reproducibly measured in 2 dimensions
Lesion amenable to treatment with both PLA and HIGRT; for PLA treatment this requires the lesion be visible via ultrasound and/or non-contrast CT or feasible per treating physician
Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured.
At least one radiologically measurable lesion as per RECIST 1.1
Participant must have at least one biopsiable lesion in the Phase 1 portion. In the Phase 2 part of the trial, participants must have either (a) at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or (b) at least one predominantly lytic bone lesion.
Prior embolization and/or ablation; for the dose escalation, prior embolization and ablation is allowed as long as the patient has progressed with a new RECIST measurable lesion
Local radiation therapy (RT) is allowed as needed to manage symptoms appropriately, as long as there remains a measurable lesion in the CNS
Whole-brain RT may be used, without a pre-defined washout period, prior to commencement of study therapy if the lesion that has been radiated is not the sole measurable lesion, or the patient is eligible based on positive CSF cytology
Participants must have at least one RECIST v1.1 measurable non-central nervous system (CNS) based lesions; palliative radiation must be indicated for at least one measurable or non-measurable lesions (including bone lesion), and this lesion must be a candidate for radiation to a dose of 30 Gy of radiation over 5 fractions as deemed by a treating radiation oncologist; one measurable lesion must be in a location where it will not be incorporated into the radiation fields so systemic response can be assessed; however, inclusion of patients with more than 10 measurable lesions is strongly discouraged and all patients must have life expectancy > 6 months
Surgical fixation of bone lesion to be irradiated is required and indicated to provide mechanical stability
Surgical fixation of bone lesion to be irradiated is required and indicated to provide mechanical stability
Has ?1 injectable lesion which is measurable and amenable to injection and biopsy.
Phase II: Patients with advanced/metastatic tumors in the below selected indications, with at least one measurable lesion as determined by RECIST v1.1 or RANO
At least 1 measurable lesion on imaging. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
Prior radiofrequency ablation (RFA) to index lesion
At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; a previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
At least one bidimensionally measurable lesion
At least one measurable lesion at baseline
At least one extracranial measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation.
Patients with isolated tumorous CNS-LCH (including isolated DI with mass lesion in the hypothalamus-pituitary axis). In patients with already established diagnosis of LCH and radiologic finding of CNS lesions compatible with LCH, a biopsy of the lesion is not obligatory. In all other cases a biopsy of the lesion is needed for inclusion into the study
Stratum VI -- Patients with newly diagnosed SS-LCH and localization other than \multifocal bone\,isolated tumorous CNS lesion, or isolated \CNS-risk\ lesion.
Measurable metastatic gastrointestinal epithelial cancer with at least one lesion that is resectable for TIL generation, plus one other lesion that can be measured.
One previously unirradiated lesion amenable to 8 Gy x 3 radiotherapy based on dosimetric organ tolerance AND another unirradiated measurable lesion (per irRECIST) outside of the radiation field.
Have at least one measurable lesions in the liver or at least one measurable lesion in the liver and another measurable lesion elsewhere, based on RECIST version (v.) 1.1
Radiographically measurable disease by RECIST version 1.1 in at least one site not previously treated with chemoembolization, radioembolization, radiation, or other local/liver-directed procedures (i.e. must have at least one measurable target lesion, either within the liver or in a measurable metastatic site); a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a radiologist, is acceptable
NHL only- at least one measurable lesion
Have at least 1 resectable lesion to generate TIL
Patients with pathologically confirmed MF with cutaneous involvement.\r\n* Patients must have clinically measurable disease of at least 1 lesion on physical (skin) exam.\r\n* If a patient has a prior pathological diagnosis of MF and is clinically diagnosed with a new lesion, the new lesion is eligible for enrollment without additionally biopsy confirmation.
Must have at least 1 lesion with measurable disease
An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation
At least one cutaneous lesion that is amenable to treatment with topical imiquimod
Measurable lesion; patients are required to have at least one measurable non-bone lesion ? 10 mm that has not been irradiated\r\n* Measurable metastatic disease documented by radiograph, computed tomography (CT) scan, positron emission tomography (PET)/CT, magnetic resonance imaging (MRI), or physical exam is required; each subject will be required to have at least one measurable lesion that has not been irradiated with a minimum size in at least one diameter of ? 10 mm for liver lesions, lung, skin, and ? 15 mm lymph node metastases; biopsy of recurrent site(s) is not required
Patients with at least two liver tumor lesions with at least one with a diameter of 2 cm or bigger, which is amendable for (super-)selective TATE as the target lesion. Alternatively, patients with one intra-hepatic lesion of 2 cm or bigger and exhapetic lesion(s) are also acceptable.
Prior local radiation therapy would be allowed as long as there is at least one non-irradiated index lesion
Must have at least one intrahepatic lesion amenable to SBRT
At least one measurable lesion as defined by RECIST version 1.1; previously irradiated lesions are not measurable unless the lesion has demonstrated clear progression after radiation
Patients may have received any previous therapy, including surgical excision, but must have histologically documented recurrence on new biopsy and a measurable lesion that meets the above criteria
at least 1 measurable lesion on imaging.
Presence of inoperable tumor lesion/s from histologically confirmed solid tumors or lymphomas, in patients with at least one lesion ? 1 cm and suitable for intra-lesional injection, who have disease progression after treatment with available therapies, or who are intolerant to such treatments
Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable/evaluable disease
At least one index lesion that will not undergo RT or ablation, and which is measurable based on RECIST 1.1
One previously unirradiated lesion amenable to radiotherapy 8 Gy x 3 and can meet dose constraints, and another unirradiated measurable lesion >= 1 cm in size outside the radiation field that can be used as measurable disease
At least one baseline eligible lesion. Per RECIST criteria (version 1.1), an eligible lesion at baseline is considered measurable when ? 10mm diameter in the longest diameter;
More than one primary lesion
Histologically confirmed diagnosis of initial or recurrent anal or vulvar high-grade squamous intraepithelial lesion diagnosed on or after 1/1/2014; study pathologist will use p16 staining as needed to rule out low-grade squamous intraepithelial lesion (LSIL) disease
Must have at least 1 lesion with measurable disease
Measurable disease requirements on scans: PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects should have at least 1 measurable extranodal lesion or nodal lesion
At least 1 measurable lesion
Subjects must have a CTA scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization;
Plan on having surgical treatment to remove the lesion
Radiological assessment within 21 days prior to study entry demonstrating measurable disease that includes at least one pulmonary lesion >= 1 cm in greatest dimension that would be amenable to SBRT and at least one measurable lesion that would be outside of the SBRT treatment fields
Patients must have at least 1 lesion that is measurable using RECIST guidelines\r\n* NOTE: A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST, and has clearly progressed\r\n* NOTE: For patients with infiltrative disease, evaluable disease needs to be confirmed by pathology if RECIST measurements cannot be made
Biopsy proven metastatic melanoma or non-squamous NSCLC with at least one untreated cerebral metastasis that is at least 5 mm AND twice the magnetic resonance imaging (MRI) slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment (“clinically evaluable lesion[s]”); an untreated brain metastasis is defined as a lesion not present at the time of whole brain radiation therapy or included in a stereotactic radiotherapy field (or within 2 mm of a treated lesion), or any lesion that is new or unequivocally progressing since prior radiation therapy
All patients should have either five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion; or other assessable disease
At least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion; or other assessable disease
Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation
At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy.
At least one tumor must qualify to be an index lesion for modified WHO criteria.
PHASE II: At least one measurable extra-CNS lesion based upon RECIST version 1.1; Note: participants with at least one CNS lesion >= 10 mm but no other measurable extra-CNS lesions will still be allowed to participate
At least 1 measurable lesion
At least 1 lesion with measurable disease at baseline
Patients must have at least one measurable site of disease, per RECIST 1.1, that has not been previously irradiated; if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
Must have at least 1 liver lesion amenable to SBRT with tumor size < 15 cm (single lesion or sum); up to 3 lesions will be irradiated
Patients must have at least one biopsiable measurable metastatic melanoma, lesion > 1 cm and must be amenable to undergoing serial biopsies through the course of therapy; this lesion must not be documented as one of the target lesions
Patient’s acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator)
At least one additional non-contiguous lesion to the irradiated lesion amenable to radiographic evaluation
Patients may not have received radiation to the index lesion within 1 year of enrollment
Patients who have metastatic cancer must have at least one lesion that is outside the radiation field that measures greater than one cm that can be followed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; this lesion, if it is close to the radiated lesion, must receive no more than 10% of the dose prescribed to the target lesion
Any history of systemic anti-cancer therapy (standard or experimental) completed within 30 days prior to dosing, with the exception of palliative ablation of lesion(s) as long as measurable disease lesion(s) remain for evaluation of exploratory endpoints
Prior ablative or surgical treatment of the lesion
Focal lesion visualized in its entirety colposcopically and involving =< 2 quadrants of the cervix
At least 1 measurable lesion
RAI-refractory disease on structural imaging, defined as any one of the following:\r\n* A metastatic lesion that is not radioiodine-avid on a diagnostic radioiodine scan performed prior to enrollment in the current study, or\r\n* A radioiodine-avid metastatic lesion which remained stable in size or progressed despite radioiodine treatment 6 months or more prior to entry in the study; there are no size limitations for the index lesion used to satisfy this entry criterion\r\n* The presence of at least one fluorodeoxyglucose (FDG) avid lesion
More than 1 lesion identified during baseline.
Biopsy proven metastatic melanoma or NSCLC as follows:\r\n* Patients with metastatic melanoma must have untreated brain metastases including:\r\n** At least one cerebral metastasis that requires local intervention and is amenable to craniotomy or LITT either due to symptoms, lesion size, location, edema or hemorrhage (“surgical lesion”); alternatively, a patient may be eligible if a cerebral metastasis was resected or biopsied any time prior to enrollment and there is tumor tissue available for analysis\r\n** At least one cerebral metastasis that is at least 5 mm AND twice the magnetic resonance imaging (MRI) slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment (“clinically evaluable lesion[s]”)\r\n* Patients with stage IV NSCLC with at least one cerebral metastasis that is at least 5 mm AND twice the MRI slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment (“clinically evaluable lesion[s]”)
Active herpes lesion
Ultrasound visible lesion(s)
Disease must be evaluable by metaiodobenzylguanidine (MIBG) scan; a positive MIBG scan must be present within 8 weeks prior to study entry and subsequent to any intervening therapy; if the patient has only one MIBG positive lesion and that lesion was radiated, a biopsy must be done at least 4 weeks after radiation was completed and must show viable neuroblastoma
Diffusely multifocal lesion
At least five measurable KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion
Patients must have at least one measurable CNS lesion that is asymptomatic, untreated, and does not require local therapy at the time of enrollment; measurable CNS disease is defined as a brain metastasis that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 5 mm (>= 0.5 cm) with brain magnetic resonance imaging (MRI); if the lesion is 5-10 mm in size and is the only measurable disease, MRI imaging must be performed with 1.5 mm slice thickness or less; a history of previously treated brain metastases is allowed, however any lesion present at the time of whole brain radiotherapy or included in the stereotactic radiotherapy field (or within 2 mm of the treated lesion) will NOT be considered “untreated” unless it is new or documented to have progressed unequivocally since treatment
For Parts A, B, D, and E: Must have at least 1 measurable brain lesion ?10 millimeters (mm) in the longest diameter (LD).
Patients must have measureable disease which is defined as at least one measurable lesion that can be accurately measured in 2 planes; diffuse leptomeningeal involvement (\sugar coating\) that does not allow measurement of at least one lesion in 2 planes will not be considered measurable disease
INCLUSION FOR INTRAMURAL INJECTION: \r\n* Subject must have lesion(s) amenable to HSV1716 administration by needle if superficial; by needle and/or catheter if deep or pulmonary, via interventional radiology without undue risk\r\n* Lesion(s) must meet size criteria\r\n* In the first two dose levels, subjects must have localized disease that meets size criteria; localized is defined as a single lesion; however, more than one lesion may be acceptable if they are contiguous\r\n* In the third dose level, subjects must have one to three lesions meeting size criteria\r\n* The arm (route of administration) will be chosen by the investigator and patient/parent based on multiple considerations and subject to approval by the principal investigator
Patients must have localized spinal metastasis; this includes patients with a solitary lesion, a lesion that spans two contiguous levels, a lesion with a para-spinal component, and up to three separate single vertebral levels
Have at least 1 measurable lesion of ? 1.0 cm. Confidential and Proprietary 6 ALT-803 and Pembrolizumab for NSCLC Altor BioScience Clinical Trial Protocol: QUILT-2.023
Subject has measurable disease according to RECIST 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
Patients must have at least one lesion not previously irradiated (and not within a previously irradiated field) for which palliative radiation to the abdomen and/or pelvis is potentially indicated and could be safely delivered at the radiation doses specified in this protocol; this lesion must not be within the central nervous system (CNS) (brain or spinal cord), bone or liver, and must not require urgent or emergent palliative radiation given the timing of radiation specified on this protocol; furthermore, this lesion must be located in the abdomen or pelvis and measure at least 2 cm (minimum dimension) and no greater than 6 cm (maximum dimension); palliative radiotherapy would entail involved-field radiotherapy to a single lesion or region to encompass gross disease; whole-abdomen radiotherapy would not be permitted; patients who received prior vaginal brachytherapy would be permitted to receive palliative pelvic radiation; in the expansion cohort at the maximum tolerated dose (MTD), this lesion must not be the only measurable lesion so that it is possible to determine the response rate outside of the radiation treatment field
Patients with just one measurable or evaluable tumour lesion that has been resected or irradiated prior to their enrolment in the study
Subjects must have at least one measurable lesion
Excluding the lesion intended to undergo radiation, subjects must have at least 1 unresectable, non-bony lesion that is measurable radio-graphically (based on RECIST 1.1).
patients with NSCLC, UC, mBC, or SCCHN must have measurable disease by RECIST v1.1 criteria with at least one uni-dimensional measurable lesion;
At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST (RECIST version 1.1) and no older than 28 days before start of the study treatment. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
Prior radiation treatment to the index lesion to be treated
Prior radiation which overlaps and precludes hypofractionated treatment to the index lesion
Absence of a biopsiable lesion as determined by radiologist
Patient has either measurable disease per RECIST v1.1 or at least one predominantly lytic bone lesion must be present
Must have at least 1 lesion with measurable disease
a second (distal) lesion must be accessible for baseline and on-treatment biopsy and must be distinct from the injected lesion.
The presence of radiographically measurable disease immediately prior to start of Phase I immunotherapy is not an eligibility requirement in the following situations:\r\n* In patients with NB who have documented bone marrow (BM) involvement;\r\n* In patients with NB who have MIBG-positive bony lesion(s);\r\n* In patients with OST who had to undergo resection of the pulmonary lesion(s)
Major surgery < 4 weeks or radiation therapy < 2 weeks of study entry; prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
Prior radiation allowed (no restriction on amount); measurable lesion(s) may not have been previously irradiated
For cohort 3 only, patients must be able to safely undergo pre and post-treatment biopsy, i.e., at least one readily accessible lesion or palpable lymph node metastasis arising from any solid tumor cancer or lymphoma\r\n* NOTE: this may include cutaneous and subcutaneous tumors using injection by palpation or ultrasound guidance\r\n* NOTE: the target lesion must be >= 1.5 cm on its longest diameter, be at least 5 mm thick, and have distinct borders\r\n* NOTE: deep seated lesion(s) that are deemed hazardous to inject or lesion(s) close to vital structures that might be impinged with tumor swelling are excluded as targeted tumor\r\n* NOTE: cohort 3 should be selected for patients with injectable cutaneous lesion(s), unless the patient elects not to receive IT injection and/or undergo pre and post-treatment biopsies
For escalation cohorts, if no measurable disease is present, then at least one predominantly lytic bone lesion must be present
At least one lesion in the brain that is measurable, which is defined as >= 5 x 5 mm; (prior craniotomy and surgical resection is allowed, as long as there is at least one remaining measurable lesion in the brain)
Previous radiotherapy to the lesion(s) of interest, including prior treatment with whole-brain radiation therapy (WBRT); (prior treatment with SRS is allowed if the index lesion[s] is in a different, non-contiguous location than the previously treated lesion)
Must have a skin lesion of at minimum 2 cm, in a location amenable to radiation and a minimum of 2 additional measurable skin lesions distant from the radiation site
More than one primary lesion
Patients must have at least one 1.5 cm bidimensional measurable lesion
Radiographically measurable disease by RECIST version 1.1 in at least one site not previously treated with chemoembolization, radioembolization, or other local ablative procedures (i.e. must have at least one measurable target lesion, either within the liver or in a measurable metastatic site); a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a radiologist, is acceptable
Measurable disease at least one lesion ? 1.5 cm for NHL and ALC > 5,000 for CLL
Patients must have at least one lesion that meets the definition of measurable disease by RECIST 1.1
Prior stereotactic radiotherapy (SRT) and prior excision of up to 3 melanoma brain metastases is permitted if there has been complete recovery, with no neurologic sequelae, and measurable lesions remain. Growth or change in a lesion previously irradiated will not be considered measurable. Regrowth in cavity of previously excised lesion will not be considered measurable. lesions or prior excision must have occurred ? 3 weeks before the start of dosing for this study
A minimum of 1 measurable lesion by CT or MRI
Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated
Patient has either measurable disease per RECIST 1.1 criteria OR at least one predominantly lytic bone lesion must be present
Subjects must have at least one lesion amenable to biospy
If patients have had a potential index lesion radiated, it must have progressed post radiation therapy to be used as a measurable eligibility lesion
Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
Must have at least 1 lesion with measurable disease
At least one prior treatment to a central nervous system (CNS)-based lesion is required; prior therapy must be completed > 2 weeks prior to enrollment; a previously treated lesion must be demonstrated by MRI to have progressed following treatment in order to be eligible; the subsequent development of a new CNS lesion that was not previously treated will be permitted and does not require treatment followed by progression prior to enrollment; treatment of a single CNS lesion with local therapy in the context of multifocal disease is permitted as long as at least one untreated lesions meets criteria for measurable disease; patients should have received minimum of one line of systemic therapy
Patients must have at least 1 lesion that is measurable using RECIST guidelines.
At least one measurable lesion
Patient must have either measurable disease by RECIST 1.1 or at least one predominantly lytic bone lesion.
Patient has at least one measurable lesion (>= 2 cm) according to Cheson criteria
For patients with neither LM nor measurable BM: At least one measurable extracranial lesion. For patients with measurable BM but without LM: at least one measurable intracranial lesion
Hepatic lesion
The lesion is suitable for repeat measurement
Patient must have appearance of at least one new bone lesion
Phase 1 patients must have at least two measurable tumor lesions ? 1.0 cm that are accessible to biopsy. Phase 2 patients must have at least one measurable lesion (per RECIST v1.1) which may be the same site that is used for the intratumoral injections.
Patient has at least one measurable lesion (>= 2 cm) according to Lugano classification
At least one index lesion that will not undergo RT and which is measurable based on RECIST 1.1
Absence of lytic bone lesion
Radiation therapy within 2 weeks of starting the study treatment; prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
At least one index lesion that will not undergo RT or ablation, and which is measurable based on RECIST 1.1
If no measurable disease is present, then at least one predominantly lytic bone lesion must be present
Visible uptake in at least one lesion on bone scanning prior to radium therapy
At least 1 measurable lesion at baseline;
In addition to index lesion, there are >= 1 measurable lesion(s)
Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator)
Subjects must have at least 1 lesion
Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
At least 1 measurable lesion at baseline
At least one lesion, not previously irradiated.
RAI-refractory disease on structural imaging, defined as any one of the following: \r\n* A metastatic lesion that is not radioiodine-avid on a diagnostic radioiodine scan performed up to 2 years prior to enrollment in the current study, or \r\n* A radioiodine-avid metastatic lesion which remained stable in size or progressed despite radioiodine treatment 6 months or more prior to entry in the study; there are no size limitations for the index lesion used to satisfy this entry criterion\r\n* The presence of at least one fluorodeoxyglucose (FDG) avid lesion with a maximum standardized uptake value (SUVmax) >= 5
a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For Expansion Phase: At least one measurable lesion.
Measurable (RECIST) indicator lesion not previously irradiated.
Patient must have either: • Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other locoregional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented). OR • If no measurable disease is present, then at least one predominantly lytic bone lesion must be present (Patients with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation).
At least one measurable untreated lesion
Patients must have measurable disease in the brain, defined as at least 1 lesion measuring >= 5 mm on imaging
Patients who underwent radiosurgery to treat a progressive lesion must have confirmation of tumor by tissue, magnetic resonance spectroscopy (MRS), magnetic resonance (MR) perfusion or positron emission tomography (PET) and the lesion must be measurable; NOTE: radiosurgery may be done to a lesion that will not be used for response evaluation and should be done > 2 weeks prior to enrollment
At least one measurable lesion on screening CT or MRI
Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion with identifiable soft tissue components that can be evaluated by MRI or CT, that is measurable (>= 15 mm at baseline) and can be followed serially by RECIST v 1.1
At least one measurable lesion as defined by modified RECIST version 1.1; previously irradiated lesions are not measurable unless the lesion is new or has demonstrated clear progression after radiation
At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST (RECIST version 1.1), and modified RECIST for HCC. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
Subjects must have at least 1 measurable lesion.
Dose Expansion phase: At least 1 measurable lesion which has not been treated previously with radiotherapy. A newly arising lesion in a previously irradiated field is acceptable
Certain type(s) of non-measurable lesion(s), if the only one(s).
Treatment of any bone lesion is permissible if it is anticipated that the dosimetry guidelines can be met
Patient has at least one measurable nodal lesion (>= 2.0 cm)
Evidence of objective disease. A measurable lesion is not necessary.
a) Dose Evaluation Portion: Patients should have at least one lesion accessible for intratumoral injection and biopsy. b) Melanoma Expansion Cohort: Patients must have at least one target lesion by Response Evaluation Criteria for Solid Tumors (RECIST v1.1), with at least one lesion accessible for intratumoral injection. Tumor biopsies are not required in the expansion cohort.
Both naive and previous systemically treated patients are included \r\n* Prior chemotherapy or immunotherapy is permitted\r\n* Prior investigational agents are permitted, however, no prior treatment with targeted therapies directed to c-KIT/PDGFR allowed (e.g., imatinib or sunitinib)\r\n* Limb perfusion allowed\r\n* If radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that lesion to constitute measurable disease or to be included in the measured target lesions
Patients are only eligible if complete tumor resection is not feasible, or if a patient with a surgical option refuses surgery; patients must have measurable residual tumor present; for the purpose of this study a measurable lesion will be defined as a lesion of at least 3 cm measured in one dimension; evidence of recurrent or progressive disease is NOT necessary; patients must be at least 21 days from surgery, if performed, prior to receiving their first dose of study drug
At least one measurable lesion
All patients must have at least one lesion deemed safe to biopsy and be willing to undergo mandatory baseline biopsy; it is preferred that this lesion be a lesion that progressed or arose while on the prior PARP therapy
Extra-osseous extension of metastatic lesion is >10mm,
At least one lesion measurable by RECIST not previously irradiated (Monotherapy and in Cohorts A and B)
Previous local therapy of any KS-indicator lesion unless the lesion has clearly progressed since treatment; any prior local treatment to indicator lesions regardless of the elapsed time is not allowed unless there is evidence of clear-cut progression of said lesion
Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation; the lesion must be at least 1 cm in diameter that can be surgically removed with minimal morbidity (defined as any operation for which expected hospitalization =< 7 days)
Confirmed and measurable metastatic melanoma with at least one measurable lesion for evaluation of response
Has at least one confirmed measurable metastatic lesion
Previous local therapy of any KS-indicator lesion unless the lesion has clearly progressed since that local treatment; any prior local treatment to indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion
At least one bidimensionally measurable lesion
Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
Lytic lesion requiring an impending orthopedic intervention
Subjects must have at least 1 measurable lesion.
At least 2 sites of measurable disease per Cheson criteria (must measure at least 1.5 cm in any diameter or 1.0 cm in the shortest diameter if one of the diameters is not ? 1.5 cm), one of which must be palpable and easily accessible in a low-risk site (eg, inguinal, axillary, cervical, subcutaneous) for intratumoral injection (denoted as \Lesion A\ in Treatment Cycle 1) and at least one additional untreated lesion that is located outside the radiation field of the treated lesion (Lesion A) and is accessible for an FNA aspirate.
Lytic lesion requiring an impending orthopedic intervention
At least one radiologically-confirmed and measurable metastatic brain lesion ( ? 0.5 cm)
Measurable disease, as determined by radiologist evaluator, with at least 1 unidimensional measurable lesion (target lesion) by RECIST v.1.1 that has not previously been irradiated or biopsied
Documented presence of at least one metastatic lesion of the humerus.
At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area
Patients must have at least one lesion suitable for perfusion CT; the lesion should be greater than or equal to 3 cm in size in the cranial caudal direction
Lytic lesion requiring an impending orthopedic intervention
Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable/evaluable disease
Must be able to undergo MRI and have at least one measurable intracranial lesion for which specific criteria have to be met.
Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection.
Must have measurable disease (RECIST v1.1) in at least one lesion not previously irradiated unless documented evidence of progression
At least 1 measurable lesion per RECIST v1.1; subjects whose only measurable lesion is a lymph node will be excluded
Lytic lesion requiring an impending orthopedic intervention
Patient has at least one measurable and/or non-measurable lesion as per RANO criteria
At least 1 osteolytic bone lesion
at least one cutaneous lesion (each lesion ? 10 mm in longest diameter or up to 5 lesions having a sum of longest diameters ? 10 mm); and/or
at least one subcutaneous lesion (each lesion ? 10 mm in longest diameter by CT);
At least 1 lesion with measurable disease at baseline
Patients must have at least one measurable PN, defined as a lesion of at least 3 cm measured in one dimension; patients who underwent surgery for resection of a PN are eligible provided the PN was incompletely resected and is measurable
At least one unidimensionally measurable lesion meeting RECIST v1.1 criteria
Dose escalation: Patients with metastatic melanoma with measurable, stage III (in transit lesions) or stage IVA, IVB or IVC disease (at least 2 measurable lesions/tumors; patients will be required to have one more lesion resent than the number the current dose level requires since one lesion will be left untreated
Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation, plus one other lesion that can be measured
Has measurable disease (or evaluable if not in MTD expansion cohort) via computed tomography (CT) or magnetic resonance imaging (MRI) scans with or without non-measurable tumors (a lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of that lesion prior to enrollment)
Diagnosed with DCIS, LCIS, ADH, or ALH (the most recent, highest risk lesion is the “index lesion”) between January 1, 2012 and September 30, 2016
Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
Patient whose bone-lesion interface is < 10-mm from the skin
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Palpable lesions that are not measurable by radiographic or photographic evaluations may not be utilized as the only measurable lesion. Any measurable lesion biopsied at Screening cannot be followed as a target/index lesion unless agreed upon by GlaxoSmithKline (GSK).
Groups 1, 2 and 3: At least 1 measurable lesion defined by mRECIST 1.1 for patients with GIST.
?1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 that has not been previously treated with locoregional therapy. A participant with a lesion(s) that has previously been treated with locoregional therapy is also eligible, if the lesion has documented progression after locoregional treatment and is measureable.
Radiologic evidence of at least 1 measurable lytic lesion in the arm, pelvis or leg
Measurable disease – minimum lesion size of 8 x 3 mm before initial biopsy
Progressive enhancement (> 25% increase in contrast enhancing volume compared to nadir or a new measurable lesion) on MRI performed within 28 days of registration, and >= 42 days since completion of standard radiation/temozolomide therapy; measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm, and at least 10 mm in the 3rd orthogonal direction
A BIRADS 5 lesion
Participants must have measurable brain disease, defined as at least one lesion that is 10 mm in diameter
No chemotherapy for at least 4 weeks and no radiation to the index lesion or clear progression in that lesion (greater than 20% increase in longest diameter)
Has undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast
Patient must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by radiological evaluation (ultrasound, mammography, magnetic resonance imaging [MRI], computed tomography [CT], PET) or physical examination\r\n* Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible\r\n* Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic duct; decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP
Patients with a lesion < 2 mm
Patient has at least 1 focal lesion in liver
New or increased enhancing brain lesion(s) OR nonenhancing brain lesion(s) if receiving anti-angiogenic therapy, which is considered indeterminate for tumor progression versus (vs) radiation injury by the neuroradiologist or clinician
Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia)
Subject has oral lesion
Male or female patients with metastatic non- hematological solid tumors, with one or more brain metastases, of which at least one lesion has a diameter ?1.5 cm, as confirmed by anatomical imaging (GBCA-enhanced MRI), wherein this lesion (or lesions) is scheduled to be treated by SRS.
Subjects with at least 1 lesion of tumor of the breast
Patients with a solid lung lesion 1.5-5cm identified on chest computed tomography (CT) (obtained within previous 3 months) with the intention to undergo bronchoscopic evaluation; if the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up > 75% of the lesion and measure at 1.5-5cm; the decision to pursue biopsy will be made by the treating physician and agreed upon by the patient; this will include patients determined to have an intermediate risk of malignancy (5-65%) and those non-surgical candidate with higher risk lesions in need of diagnosis for alternative treatment; OR
Patients with a solid lung lesion 1.5-5cm identified on chest CT (obtained within previous 3 months) that are surgical candidates with a high probability of cancer (> 65%) will be referred for surgical evaluation; if the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up > 75% of the lesion and measure at 1.5-5cm; if the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study; all sites will use the same online calculator to document probability of malignancy
Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion[s] or worsening of known lesion(s) based on imaging modalities or physical examination
At least 1 measurable lesion on CT or MRI
Lesion accessible for size measurement and photography.
Subject presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted BBB (e.g., primary and secondary tumors, focal inflammatory or demyelinating disorders) including at least one expected enhancing lesion of minimum 5 mm (long axis). This lesion must have been detected on a previous imaging procedure (computerized Tomography (CT) or MRI).
Have a lesion or biopsy marker that is visible under ultrasound
Have a lesion in which the center/focal area is defined
Hepatic lesion: The lesion can be accurately measured in at least one dimension as ?1.0 cm
The lesion is suitable for repeat measurement
Nonhepatic lesion
At least one lesion with measurable disease at baseline
Measurable disease as per modified RECIST 1.1 • A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization
At least one measurable lesion