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Germ Cell CancerPhase 1/2NCT07850973

Phase 1/2 Study Of PARP Inhibition With Olaparib To Enhance The Efficacy Of High-Dose Chemotherapy In Refractory And Relapsed Germ Cell Tumors

A Phase 1/2 study testing Olaparib, Gemcitabine and Docetaxel in people with Germ Cell Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

The goal of this clinical research study is to find the highest safe dose of olaparib that can be combined with chemotherapy drugs and stem cell transplantation to treat patients with relapsed and refractory germ cell cancer. The safety and effectiveness of this treatment combination therapies will also be studied. Read more about this study

Who is it for?
Ages 12 to 60 years
Conditions the study is for
Germ Cell Cancer
What is being tested?
Olaparib, Gemcitabine and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
1 Mar 2027to 31 Dec 2031
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 12 - 60 years of age.
  • Diagnosis of relapsed GCT, with one or more of the following criteria:
  • Extragonadal primary.
  • >2 prior relapses.
  • Unresponsive disease (PD or SD) to the immediately prior therapy.
  • ECOG PS ≤ 2 (Karnofsky ≥ 60%).in adults, Lansky Play-Performance Scale (LPPS) ≥ 60% in pediatric patients.
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  • A minimum apheresis collection of 5 million CD34+ cells/kg of autologous peripheral blood progenitor cells (PBPC).
  • Adequate blood counts (WBC ≥ 2K, HGB ≥ 8 g/dL, platelets ≥ 50K).
  • Creatinine clearance ≥ 50 ml/min/1.73 m2 (estimated by the Cockroft-Gault method in adults and the Schwartz formula in pediatric patients) and/or serum creatinine ≤ 1.8 mg/dL.
  • ALT and/or AST ≤ 3 x institutional ULN, and bilirubin and alkaline phosphatase (ALP) ≤ 2 x institutional ULN.
  • FE 1, F and DL Oc ≥ 0%
  • L EF ≥ 0%, without active arrythmias
  • If female of child-bearing potential, she must not be pregnant or breastfeeding and required to have a negative urine or serum pregnancy test prior to enrollment.
  • For patients at risk for hepatitis B (HBV) reactivation (HBsAg+/negative HBV viremia, or HBsAg-/anti-HBc+) will be eligible as long as they are on suppressive antiviral therapy.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection still on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or lower.
  • Male patients and women of child-bearing potential whose partners are participating in the study must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114).
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to treatment initiation (specify timeframe) and for the duration of study treatment (and if necessary, specify how long after treatment is completed) . (Refer to Pregnancy Assessment Policy UT MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received whole pelvic radiation therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post-vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study therapy.
  • Ability to understand and willingness to sign a written informed document by patients and/ or their parents or legal guardians. Minors ages 7 and older must give their assent to participate

Who cannot join

  • Growing teratoma syndrome, defined as enlarging tumor masses with declining serum markers during chemotherapy for NSGCT.
  • Major surgery within 30 days before the initiation of study treatment.
  • Radiotherapy within 21 days prior to initiation of study treatment.
  • Patients with active CNS disease, defined as brain or meningeal metastases that are not in remission.
  • Patients with active hepatitis B, either active carrier (HBsAg+ and not on suppressive antivirals) or viremic (HBV DNA ≥10,000 copies/mL, or ≥ 2,000 IU/mL) or hepatitis C (detectable viral load by HCV RNA PCR).
  • Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients who either show chronic hepatitis C or positive hepatitis C serology.
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  • Active infection requiring parenteral antibiotics.
  • HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and CD4+ ≥ 350 cells/uL.
  • Patients who have had a previous autologous or allogeneic stem cell transplant in the previous 12 months.
  • Grade =≥ 3 non-hematologic toxicity from prior therapy not improved to grade ≤ 2.
  • Active infection requiring parenteral antibiotics.
  • Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib, gemcitabine, docetaxel, carboplatin, or etoposide or other agents used in study.
  • Patients with uncontrolled intercurrent neurological illness.
  • Pregnant women are excluded from this study because olaparib, gemcitabine, docetaxel, carboplatin, or etoposide are agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with those agents, breastfeeding should be discontinued if the mother is treated with any of those agents. These potential risks may also apply to other agents used in this study.
  • Patients who are receiving any other investigational agents.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yago Nieto, MD, PHD contact

(713) 794-1752

ynieto@mdanderson.org

United States1 site

  • UT MD Anderson

    Houston, Texas, 77030

    Yago Nieto, MD, PHD, 713-794-1752, ynieto@mdanderson.org

    Yago Nieto, MD, PHD

Other trials in United States

About this study

The goal of this clinical research study is to find the highest safe dose of olaparib that can be combined with chemotherapy drugs and stem cell transplantation to treat patients with relapsed and refractory germ cell cancer. The safety and effectiveness of this treatment combination therapies will also be studied.

Read the detailed description

Primary Objectives:

  1. To identify the optimal dose of Olaparib/GemDC and Olaparib/CE with ASCT in patients with R/R GCT.
  2. To establish the preliminary efficacy of sequential cycles of Olaparib/GemDC and Olaparib/CE with ASCT in patients with R/R GCT through the primary study endpoint (2-year RFS rate).

Secondary Objectives:

  1. To establish the safety and describe the toxicity profile of the study treatment.
  2. To evaluate the antitumor activity of the study treatment by determining the following secondary endpoints: Overall response rate (ORR) and complete response (CR) rate.
  3. To evaluate 2-year overall survival (OS) rate.
  4. To determine whether serial tumor-informed ctDNA dynamics (Signatera) predict response and survival.
  5. To conduct comprehensive correlative studies of treatment-associated transcriptional and proteomic changes in PBMNCs from trial patients.
Medical subject headings
Neoplasms, Germ Cell and Embryonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Also called Lynparza

    Given by mouth twice daily

  • GemcitabineDrug

    Also called Gemzar, Infugem, Inlexzo, Avgemsi

    Given by mouth twice daily

  • DocetaxelDrug

    Also called Taxotere

    Given by IV

  • CarboplatinDrug

    Also called Paraplatin, Paraplatin NovaPlus, Kyxata, Carboplatin Novaplus

    Given by IV

  • EtoposideDrug

    Also called VePesid, Toposar, Etopophos

    Given by IV

  • Autologous Stem-Cell Transplant (ASCT)Procedure or surgery

    Given by IV

Study groups in NCT07850973
Study groupRoleWhat they receive
Stage 1 Escalation and Stage 2 Expansion: Sequential Treatment with Olaparib/GemDC + Olaparib/CEExperimentalTreatment will be administered on an inpatient basis.
Receives: Drug: Olaparib; Drug: Gemcitabine; Drug: Docetaxel; Drug: Carboplatin; Drug: Etoposide; Procedure: Autologous Stem-Cell Transplant (ASCT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0

    Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start1 Mar 2027 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07850973
Sponsor's protocol ID
2026-1015
Other IDs
NCI-2026-07268
Status last verified
Sep 2026
First submitted
28 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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