-Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage IV SCCA or recurrent. The primary diagnosis of SCCA should be established using the current WHO/IASLC-classification of Thoracic Malignancies. Mixed histologies are not allowed.
-To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (Stages I-IV). At least one of these lines of therapy must have been a platinum-based chemotherapy regimen. Patients must have progressed following the most recent line of therapy. For patients whose prior systemic therapy was for Stage I-III disease only (i.e. patient has not received any treatment for Stage IV disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy.
-To be eligible for pre-screening, current treatment must be for Stage IV disease and patient must have received at least one dose of the current regimen. Patients must have previously received or currently be receiving a platinum-based chemotherapy regimen. Patients on first-line platinum-based treatment are eligible upon receiving Cycle 1, Day 1 infusion.
-Patients must not have a known EGFR mutation or ALK fusion.
-Patients must have Zubrod performance status 0-1

Substudy K eligibility:
- Patients must be assigned to this substudy.
-Patients must have pathologically proven squamous cell carcinoma of the lung
-Patients must not have peripheral edema > Grade 1, or peripheral neuropathy > Grade 1 at the time of sub-study registration.
-Patients must not have received prior treatment with c-Met pathway inhibitors.
-Patients with extensive metastatic liver disease will not be eligible.

*MCRC is not a selected institution for the repeat biopsy substudies.*

-Patients must have histologically or cytologically confirmed Stage IV or recurrent non-small cell lung cancer (NSCLC).
-Patients must have documented presence of an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation. T790M mutation or other molecular abnormality will be allowed as long as it accompanies one of these mutations.
-Patients must have tissue available and must agree to submission of tissue and blood
-Patients must not have received any prior systemic anticancer therapy for advanced or metastatic disease including chemotherapy or EGFR tyrosine kinase inhibitor therapy (including gefitinib, erlotinib, afatinib, or any experimental EGFR TKI agents).
-Prior chemotherapy for non-metastatic disease (i.e. adjuvant therapy or concurrent chemo-radiotherapy) is allowed as long as >12 months has passed since completion of therapy. Adjuvant EGFR-directed therapy is not allowed. Local therapy (i.e. palliative radiotherapy) is allowed as long as a period of 7 days has passed since the last dose was received and the patient has recovered from any associated toxicity at the time of registration.
-Patients may have measurable or non-measurable disease. Laboratory parameters are not acceptable as the only evidence of disease.
-Patient must not have symptomatic brain metastases or evidence of leptomeningeal carcinomatosis. Patients with asymptomatic brain metastases are eligible if off of steroids for at least 7 days prior to registration without development of symptoms.
-Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g. Crohn’s disease, malabsorption, etc).
-Patients must not have had major surgery within 28 days prior to registration or be scheduled for surgery during the projected course of protocol treatment.
-Patients must have Zubrod PS 0 - 2

*Credentialing required. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
Genesys Hurley, Hurley, St. John, Macomb, Sparrow, St. Alphonsus, Allegiance, Saginaw, Lehigh Valley 

-Patients must have completely resected melanoma of cutaneous origin or of unknown primary in order to be eligible for this study. Patients must be classified as Stage IIIA (N2a), IIIB, IIIC, or Stage IV melanoma. Patients with melanoma of mucosal or other non-cutaneous origin are eligible. Patients with melanoma of ocular origin are not eligible. Patients with a history of brain metastases are ineligible.
-Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site.
-Patients with multiple regional nodal basin involvement are eligible. Gross or microscopic extracapsular nodal extension is permitted.
-For all patients, all disease must have been resected with negative pathological margins and no clinical, radiologic, or pathological evidence of any incompletely resected melanoma. Patients must be registered within 98 days of the last surgery performed to render the patient free of disease.
-Patients may have received prior radiation therapy, including after the surgical resection. All adverse events associated with prior surgery and radiation therapy must have resolved to less than or equal to Grade 1 prior to registration.
-Patients must not have had prior immunotherapy.
-Patients must not have had previous treatment with ipilimumab
-Zubrod PS must be 0-1.

Study closed to accrual for SJMH and Livonia effective 1/27/2020

**Group #1 Closed to Accrual- Effective 12/02/19**

*Cancer Care and Delivery Trial*
*Check for eligibility to DCP-001

Limited Participation: SJMH, Livonia, St. John and St. Alphonsus.
-Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer. Cancer may be metastatic or nonmetastatic.
-Patients must be planning to receive one of the study-allowed regimens listed in Appendix 18.1 as their initial treatment for their current diagnosis.
-Patients must be registered prior to their first cycle of systemic therapy (chemotherapy, immunotherapy, biologic therapy, or combination regimens) for this diagnosis. If patient has had any prior systemic therapy for another malignancy, patient must not have had any systemic

therapy in the 180 days just prior to registration.

**Effective 06/23/2020, the BAHO Substudy is Closed to Accrual.**

**Effective 06/30/21, Step 1 Registration is Closed to Accrual.**

**Effective 08/31/21, Step 2 Registration is Closed to Accrual.**

CREDENTIALING REQUIRED. Please check your site's credentialing status.

DTL Required- Physicians must sign the toxicity grid
CURRENT SITES CREDENTIALED:
SJMH, Livonia, Sparrow, Saginaw, SJMO, Genesys Hurley, Hurley, St. John, LVHN

STEP 1:

-Patients must have histologically confirmed ER-, PR- and HER2-negative (TNBC) with residual invasive breast cancer after completion of neoadjuvant chemotherapy. Residual disease must be at least 1 cm in greatest dimension, and/or have positive lymph nodes (ypN+) observed on pathologic exam.
-Patients must not have metastatic disease.
-Patients must have had neoadjuvant chemotherapy followed by surgery. The recommended neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy regimen as recommended by NCCN guidelines for triple negative breast cancer. Patients who cannot complete all planned treatment cycles for any reason are considered high risk and therefore are eligible for the study if they have residual disease.
-Patients must have resolution of AEs of the most recent prior chemotherapy to Grade 1 or less, except grade 2 alopecia and neuropathy which are allowed.

-Adjuvant chemotherapy, if administered, must have been completed within 35 days prior to screening registration and must be given prior to radiation.
-Patients must have completed their final breast surgery with clear resection margins for invasive cancer and DCIS within 90 days prior to screening registration for patients not receiving adjuvant chemotherapy, or within 210 days prior to screening registration for patients who have completed adjuvant chemotherapy. Positive margins are allowed only if the surgical team deems further resection impossible.
-Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs.
-ECOG PS must be 0-2
-Patients must not have active autoimmune disease that has required systemic treatment in past 2 years

STEP 2:
-Patients must not be registered to Step 2 until receiving confirmation from the SWOG Statistical Center that the patient's tissue specimen was adequate for PD-L1 testing. Patients must be registered within 7 days of receiving the e-mail notification confirming submission was evaluable for PD-L1 status.
-Patients must continue to meet step 1 eligibility.

CTA Arms 1 and 2 (Effective. 11/01/2024) ; Re-Activation Arm 3 (Effective 11/01/2024)

H & P - pulse & BP must be taken both sitting & standing

Sites must have Validated ECHO lab.

Current sites credentialed:  SJMH, LVHN
-Patients must have metastatic breast cancer and be initiating or continuing trastuzumab–based HER-2 targeted therapy without concurrent anthracyclines in first or second line setting.
-Patients must be at increased risk for cardiotoxicity
-Patients must not be currently taking or planning to take during study treatment the following medications:

B2 agonists, Bosutinib, Ceritinib, Floctafenine, Methacholine, Pazopanib, Ribastigmine, Vincristine, Silodosin
-Patients must have a Zubrod Performance Status of 0-2.
-Patients must have LVEF greater than or equal to 50%

***Credentialing required- Check Your Sites Status***

Current sites credentialed: SJMH, Sparrow

-Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days prior to registration
-Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration
-Patients with T1 disease must have re-resection confirming ? T1 disease within 90 days prior to registration.
-Patients must have high-grade bladder cancer
-Patients must not have pure squamous cell carcinoma or adenocarcinoma.
-Patients’ disease must not have micropapillary components.
-Patients must have no evidence of upper tract (renal pelvis or ureters) cancer
-Patients must not have nodal involvement or metastatic disease.
-ECOG PS must be 0-2
-Patients must not have received prior intravesical BCG.

Effective 01/15/2023, Arm 1 - TGR-1202 plus Obinutuzumab is Closed to Accrual.

*Credentialing required. Please check your site's credentialing status.*
CURRENT sites credentialed:
SJMH, St. Mary's Saginaw, Livonia, Oakland, LVHN, St. John, Sparrow

-Patients must have follicular lymphoma (Grade I, II or IIIa) confirmed at initial

diagnosis and at relapse with identifiable FDG avid disease on PET/CT.

-Patients must not have clinical evidence of central nervous system involvement by lymphoma,

-Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing first line bendamustine containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of bendamustine. Relapsed patients must not have received any intervening chemotherapy

-Patients must have received at least 3 cycles of bendamustine as first line therapy

-Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide

-Zubrod PS must be 0-2

**Effective 03/15/23, all cohorts are closed to patient accrual.**

*The following cohorts are Closed to Accrual:

Effective 07/01/2022, Cohort #38 (perivascular epithelioid cell tumor)

Effective 12/08/2021, Cohort #18 (Squamous cell carcinoma variants of the genitourinary (GU) system)

Effective 11/19/21, Cohort #53 (Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC))

Effective 11/01/2021, Cohort #29 (Malignant Giant Cell Tumors)

Effective 05/05/2021, Cohort #41 (Basal cell carcinoma)

Effective 04/14/2021, Cohort #4 (Undifferentiated carcinoma of gastrointestinal (GI) tract) 

Effective 04/14/2021, Cohort #27 (Desmoid tumors)

Effective 11/17/2020, Cohort #35 (Vulvar cancer)

Effective 11/17/2020,  Cohort #48 (Gallbladder cancer)

Effective 11/01/2020, Cohort #21 (Odontogenic malignant tumors) Effective 1/01/2020, Cohort #42 (Clear cell cervical cancer)

Effective 07/29/2020, Cohort #51 (Angiosarcoma) 

Effective 04/09/2020, Cohort #45 (Clear cell cervical endometrial cancer)

Effective 03/11/2020, Cohort #22 Pancreatic neuroendocrine tumor (PNET)

Effective 02/19/2020- Cohort #39 (Apocrine tumors/Extramammary Paget’s Disease)

Effective 02/03/2020- Cohort #52 (High-grade neuroendocrine carcinoma)

Effective 02/03/2020- Cohort #26 (Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex)

Effective 01/15/2020- Cohort 24 (Pheochromocytoma, malignant)

Effective 10/22/19, Cohort #36 (MetaPLASTIC carcinoma of the breast)

Effective 10/02/19- Cohort #17 (Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis)

Effective 09/01/19- Cohort #43 (Endometrial carcinosarcoma (malignant mixed Mullerian tumors)

Effective 08/15/19- Cohort #8 ( Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma.

Effective 06/11/19- Cohort #44 ( Endometrial carcinosarcoma (malignant mixed Mullerian tumors).

Effective 06/11/19- Cohort #3 (Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location. 

Effective 05/15/19 Cohort #16 (Cell Tumor of the Testes and Extragonadal Germ Tumors)
Effective 04/15/19 Cohort #14 (Trophoblastic tumor: A. Choriocarcinoma)
Effective 04/15/19 Cohort #15 (transitional cell carcinoma other
than that of the renal, pelvis, ureter, or bladder)
Effective 03/15/19 Cohort #33 ( Not Otherwise Categorized (NOC) Rare Tumors)

Effective 10/17/18- Cohort #6 (Squamous cell carcinoma with variants of GI tract (stomach, small intestine, colon, rectum, pancreas) 

Effective 09/26/18- Cohort #37 -(Gastrointestinal stromal tumor) 

Effective 09/19/18- Cohort #28- Peripheral nerve sheath tumors and NF1-related tumors

Effective 07/27/18-  Cohort #1 – Epithelial tumors of the nasal cavity, sinuses, nasopharynx

Effective 07/27/18-Cohort #20 – Adenocarcinoma with variants of GU system

Effective 07/27/18-  Cohort #22 – Endocrine carcinoma of pancreas and digestive tract

Effective 06/27/18- Cohort #31 (Adrenal cortical tumors)

Effective 05/10/18-Cohort #5 (Adenocarcinoma with variants of small intestine) 

Effective 03/20/18- Cohort #7 (Fibromixoma and low grade mucinous adenocarcinoma

(pseudomixoma peritonei) of the appendix and ovary Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary

Effective 03/20/18-Cohort #9- (Intrahepatic Cholangiocarcinoma),

Effective 03/20/18-Cohort  #10- Extrahepatic cholangiocarcinoma and bile duct tumors

Effective 03/30/18- Cohort #13 (Non-epithelial tumors of the ovary)

Effective 03/20/18- Cohort #2 (Epithelial tumors of major salivary glands)

Effective 12/19/17- Cohort #23 (Neuroendocrine carcinoma including carcinoid of the lung)

Effective 12/22/17-  Cohort #32 (Tumor of unknown primary, cancer of unknown primary)
-Effective 02/06/18 Cohort #34 (Adenoid cystic carcinoma)

-Patients must have histologically confirmed rare cancer and/or cancer of unknown  primary, identified in protocol section 18.1 that did not have a match to a molecularly -  

guided therapy on MATCH or who progressed on molecularly-matched therapy and have no further molecularly-matched treatment recommendations
-Patients who are determined to have a rare cancer with unknown primary site are eligible provided that there is histologic documentation of metastatic malignancy with no discernible primary site
-Patients must have measurable disease.
-Patients may have received either prior anti-CTLA4 or other prior anti-PD-1/anti-PD-L1 therapy, not both, provided that it is completed at least 4 weeks prior to registration

for monoclonal therapy, at least 8 weeks prior to registration if therapy involved immune stimulatory mAbs, and at least 28 days for all other immunotherapy
-Patients who had prior immune-related adverse event are not eligible.
-Patients must have a ECOG PS of 0-2.
-Patients must not have active autoimmune disease that has required systemic treatment in past 2 years