Pivotal Trial

No Placebo-Only Group

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.

PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

High-Dose Interferon Alfa for Melanoma

This study is evaluating whether interferon alfa can improve survival for people with melanoma.

My skin cancer is at Stage II with a thickness of 1.5-4.0 mm.

My lymph nodes do not show signs of cancer, either by clinical exam or biopsy.

My cancer is stage III with a tumor thicker than 4mm or has spread to one lymph node.

Interferon alfa-2b

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for metastatic colorectal cancer.

PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer.

Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

Chemotherapy Regimens for Colorectal Cancer

This study is evaluating whether one of three chemotherapy regimens is more effective than the others.

I have had a condition where my lymphocytes grow abnormally.

My colon or rectum cancer has spread and cannot be cured with surgery or radiation.

I can perform most of my daily activities without assistance.

My liver function tests are within the required limits.

My heart condition is stable, and I haven't had a recent heart attack.

My cancer has worsened on scans within 6 months after my last Saltz regimen treatment.

I haven't had cancer in the last 5 years, except for skin cancer.

I do not have lung fibrosis or interstitial pneumonia.

My kidney function, measured by creatinine, is within normal limits.

Fluorouracil

Leucovorin Calcium

Oxaliplatin

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.

Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer

Combination Chemotherapy + IM-862 for Ovarian Cancer

This study is evaluating whether a combination of chemotherapy and IM-862 might be more effective than chemotherapy alone in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.

I am not currently undergoing gene therapy.

I am not currently receiving IL-2 treatment.

I have not had chemotherapy for my current cancer.

I am not currently taking any drugs that stop the formation of new blood vessels.

I have not had radiation for my current cancer.

I have stage III ovarian or primary peritoneal cancer.

I had surgery to reduce my tumor size within the last 6 weeks.

My surgery removed the cancer well, leaving no large remaining tumors.

All my cancer outside the reproductive tract has been removed.

My liver function tests are within normal ranges.

My kidney function tests are within normal ranges.

I haven't had any other cancer in the last 5 years.

I don't have any serious illnesses that would shorten my life.

I am in good overall health with no major medical or social issues affecting study participation.

I can take care of myself but might not be able to do heavy physical work.

I have had surgery to remove my uterus, ovaries, and fallopian tubes.

I have not received IL-2 treatment recently.

I have not received hormone therapy for my current cancer.

I am not receiving any other chemotherapy treatments.

I haven't had biologic therapy for my current cancer.

Combination Chemotherapy

IM-862

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy.

PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal cancer.

Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer

Vaccine + Chemotherapy for Colorectal Cancer

This study is evaluating whether chemotherapy and vaccine therapy with or without tetanus toxoid might be more effective than chemotherapy alone in treating patients with metastatic colorectal cancer.

I am fully active or can carry out light work.

I do not have HIV, autoimmune diseases, allergies to egg or neomycin, and no bad reactions to tetanus vaccines.

I haven't had radiotherapy on more than half of my lymph nodes and no current radiotherapy affecting my bone marrow.

My lung condition is under control and not worsening.

My liver function tests are within the required limits and I don't have liver cirrhosis.

My cancer is a type of colorectal cancer that has spread.

I don't have ongoing major bowel issues or chronic diarrhea.

I have not had CEA-targeted immunotherapy or any other immunotherapy at the same time.

I haven't had a major organ transplant and have recovered from any previous surgeries.

It's been over 6 months since my last chemotherapy for early-stage cancer, and I haven't had chemo for advanced cancer.

I am not taking daily steroids or hormone therapy that isn't for replacement.

My heart condition is stable with no uncontrolled issues.

Chemotherapy

Tetanus Toxoid

Vaccine Therapy

All Individual Drugs Already Approved

Approved for 10 Other Conditions

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

Letrozole for Hormone Receptor-Positive Breast Cancer

This study is evaluating whether a drug called letrozole can help treat breast cancer.

You cannot participate in this study if you have any of the following conditions:

You have had a bone fracture in your wrist, hip, or spine that was not caused by an injury.

If you have high cholesterol, you must have it under control with medication or lifestyle changes for at least one year. If you have a history of diabetes, high blood pressure, obesity, smoking, high triglycerides, heart disease, or a family history of early-onset heart disease, you may not be eligible to participate.

You have had another type of cancer in the past, but you are considered to be cured for at least 5 years, and your doctor believes the cancer is unlikely to come back. However, if you had certain types of non-invasive cancers in the past 5 years, you may still be eligible.

Letrozole

Placebo

The purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

Erdafitinib for Bladder Cancer

This study is evaluating whether a drug may help treat cancers of the bladder.

Erdafitinib

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

Entrectinib for Solid Tumors

This study is evaluating whether a drug may help treat tumors with certain gene fusions.

I have been treated with specific inhibitors for my cancer due to certain gene changes.

My cancer can be measured or seen on tests.

I finished my radiotherapy more than 14 days ago.

My cancer is advanced and tests positive for specific genetic changes.

I have a family or personal history of bone disorders.

I am still recovering from a recent surgery.

I have had heart failure symptoms or a low heart pump function in the last 3 months.

I have a history of long QT intervals not caused by medication.

I have risk factors for irregular heartbeats.

My brain involvement from cancer is either symptom-free or was treated and is now under control.

I have lung scarring or inflammation from previous treatments.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

I have a condition that affects my stomach or intestines' ability to absorb nutrients.

I can provide a tissue sample for testing unless it's medically unsafe for me.

I have had cancer treatment but not with Trk, ROS1, or ALK inhibitors for specific gene changes.

It's been over 2 weeks since my last cancer treatment.

It has been over 4 weeks since my last antibody therapy.

I can care for myself and doctors expect me to live at least another month.

I have no other cancers that would affect this trial's results.

Entrectinib

The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.

NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers).

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Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress.

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TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

Targeted Therapy for Advanced Stage Cancer

My cancer can't be measured or found through scans or exams.

I have an advanced or spreading cancer, multiple myeloma, or B cell lymphoma.

I have had brain metastases, but no seizures or major changes in my neurological status in the last 3 months.

I have a primary brain tumor or cancer that has spread to the lining of my brain.

I have results from a genetic or protein test for my cancer.

I am able to get out of my bed or chair and move around.

My blood tests for organ function are within normal ranges.

My cancer has a genetic profile that may benefit from specific FDA approved drugs in this study.

My cancer has spread to my brain and is getting worse.

Abemaciclib

Afatinib

Atezolizumab and PHESGO

Atezolizumab and Talazoparib

Crizotinib

Futibatinib

Larotrectinib

Nivolumab and Ipilimumab

Olaparib

Palbociclib

Pembrolizumab

Regorafenib

Sunitinib

Talazoparib

Temsirolimus

Trastuzumab and Pertuzumab

Tucatinib plus Trastuzumab Subcutaneous (SC)

Vemurafenib and Cobimetinib

This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.

A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)

Bevacizumab + Atezolizumab for Cancer

This study is evaluating whether a drug may help treat cancer.

I had to stop a previous study treatment due to lasting side effects.

I am eligible to continue or switch to atezolizumab therapy as my current study ends.

I do not have any serious illnesses that would make the study treatment unsafe for me.

The treatment for my condition is available and I can get it in my country.

I haven't received any cancer treatments not allowed in the main study before starting the extension study.

I stopped or can continue atezolizumab as per my previous study's rules and can get it commercially.

I have severe side effects from a previous study that haven't improved.

I am still benefiting from my current cancer treatment as determined by my doctor.

I stopped taking atezolizumab for any reason after the initial study.

I will start the extension study treatment within 7 days after my current treatment ends.

Atezolizumab

A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.

A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Immunotherapy Combinations for Pancreatic Cancer

My blood and organ function tests are within normal ranges.

I have had cancer spread to the lining of my brain and spinal cord.

I have had lung conditions like pulmonary fibrosis or pneumonitis, or my CT scan shows active pneumonitis.

I can provide a sample of my tumor for PD-L1 testing.

My cancer is a type of pancreatic cancer confirmed by lab tests.

I am fully active or restricted in physically strenuous activity but can do light work.

I agree to use birth control or remain abstinent and not donate sperm during the trial.

I do not have active hepatitis B, C, or tuberculosis.

I do not need frequent procedures to remove excess fluid from my body.

I have brain metastases that are untreated or getting worse.

My cancer got worse while I was on my first chemotherapy with 5-FU or gemcitabine.

I have only had pancreatic cancer, or any other cancer I had was low risk and over 2 years ago.

My tumor can be easily reached for a biopsy.

I have pancreatic cancer and haven't received any systemic treatment for it.

I have not had a severe infection in the last 4 weeks.

Atezolizumab + AB928

Atezolizumab + Bevacizumab

Atezolizumab + BL-8040

Atezolizumab + PEGPH20

Atezolizumab + RO6874281

Atezolizumab + Selicrelumab

Atezolizumab + Tiragolumab

Atezolizumab + Tocilizumab

Cobimetinib + Atezolizumab

Fluorouracil + Leucovorin

Gemcitabine + Nab-Paclitaxel

Oxaliplatin + Fluorouracil

Tiragolumab + PEGPH20

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

GM T Cell Therapy Long-Term Follow-Up for Cancer

I've had a gene-modified T-cell infusion in a past Celgene study and completed the follow-up.

Gene-modified (GM) T cell therapy

The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.

An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

mRNA Vaccine + Immunotherapy for Melanoma

This study is evaluating whether a combination of two drugs may help prevent recurrence of melanoma.

I have not taken steroids or immunosuppressants in the last week.

I had surgery to remove my cancer completely within the last 13 weeks.

I have not received a live vaccine in the last 30 days.

My skin cancer has spread to a lymph node and is likely to come back.

Lombardi Cancer Center Clinical Trials 2022

Trials at this site

Chemotherapy Regimens for Colorectal Cancer

Combination Chemotherapy + IM-862 for Ovarian Cancer

Vaccine + Chemotherapy for Colorectal Cancer

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